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International Journal of Clinical Oncology
Published in: International Journal of Clinical Oncology 7/2019

Open Access 01-07-2019 | NSCLC | Special Article

The Japanese Lung Cancer Society Guideline for non-small cell lung cancer, stage IV

Authors: Hiroaki Akamatsu, Kiichiro Ninomiya, Hirotsugu Kenmotsu, Masahiro Morise, Haruko Daga, Yasushi Goto, Toshiyuki Kozuki, Satoru Miura, Takaaki Sasaki, Akihiro Tamiya, Shunsuke Teraoka, Yukari Tsubata, Hiroshige Yoshioka, Yoshihiro Hattori, Chiyo K. Imamura, Yuki Katsuya, Reiko Matsui, Yuji Minegishi, Hidenori Mizugaki, Kaname Nosaki, Yusuke Okuma, Setsuko Sakamoto, Takashi Sone, Kentaro Tanaka, Shigeki Umemura, Takeharu Yamanaka, Shinsuke Amano, Kazuo Hasegawa, Satoshi Morita, Kazuko Nakajima, Makoto Maemondo, Takashi Seto, Nobuyuki Yamamoto

Published in: International Journal of Clinical Oncology | Issue 7/2019

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Abstract

According to rapid development of chemotherapy in advanced non-small cell lung cancer (NSCLC), the Japan Lung Cancer Society has been updated its own guideline annually since 2010. In this latest version, all of the procedure was carried out in accordance with grading of recommendations assessment, development and evaluation (GRADE) system. It includes comprehensive literature search, systematic review, and determination of the recommendation by multidisciplinary expert panel which consisted of medical doctors, pharmacists, nurses, statisticians, and patients from patient advocacy group. Recently, we have had various types of chemotherapeutic drugs like kinase inhibitors or immune-checkpoint inhibitors. Thus, the guideline proposes to categorize patients into three entities: (1) driver oncogene-positive, (2) PD-L1 ≥ 50%, and (3) others. Based on this subgroup, 31 clinical questions were described. We believe that this attempt enables clinicians to choose appropriate treatment easier. Here, we report an English version of the Japan Lung Cancer Society Guidelines 2018 for NSCLC, stages IV.
Literature
1.
Non-Small Cell Lung Cancer Collaborative Group (2010) Chemotherapy and supportive care versus supportive care alone for advanced non-small cell lung cancer. Cochrane Database Syst Rev 2010(5):CD007309
2.
Baggstrom MQ, Stinchcombe TE, Fried DB et al (2007) Third-generation chemotherapy agents in the treatment of advanced non-small cell lung cancer: a meta-analysis. J Thorac Oncol 2(9):845–853CrossRefPubMed
3.
Fujiwara Y, Hotta K, Di Maio M et al (2011) Time trend in treatment-related deaths of patients with advanced non-small-cell lung cancer enrolled into phase III trials of systemic treatment. Ann Oncol 22(2):376–382CrossRefPubMed
4.
Anderson H, Hopwood P, Stephens RJ et al (2000) Gemcitabine plus best supportive care(BSC)vs BSC in inoperable non-small cell lung cancer—a randomized trial with quality of life as the primary outcome. UK NSCLC Gemcitabine Group. Non-Small Cell Lung Cancer. Br J Cancer 83(4):447–453CrossRefPubMedPubMedCentral
5.
Sederholm C, Hillerdal G, Lamberg K et al (2005) Phase III trial of gemcitabine plus carboplatin versus single-agent gemcitabine in the treatment of locally advanced or metastatic non-small-cell lung cancer: the Swedish Lung Cancer Study Group. J Clin Oncol 23(33):8380–8388CrossRefPubMed
6.
Mitsudomi T, Morita S, Yatabe Y et al (2010) Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor(WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol 11(2):121–128CrossRefPubMed
7.
Maemondo M, Inoue A, Kobayashi K et al (2010) Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 362(25):2380–2388CrossRefPubMed
8.
Zhou C, Wu YL, Chen G et al (2011) Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer(OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol 12(8):735–742CrossRefPubMed
9.
Rosell R, Carcereny E, Gervais R et al (2012) Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer(EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol 13(3):239–246CrossRefPubMed
10.
Wu YL, Zhou C, Hu CP et al (2014) Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol 15(2):213–222CrossRefPubMed
11.
Yang JC, Wu YL, Schuler M et al (2015) Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol 16(2):141–151CrossRefPubMed
12.
Solomon BJ, Mok T, Kim DW et al (2014) First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med 371(23):2167–2177CrossRefPubMed
13.
14.
Goto K, Yang JCH, Kim DW et al (2016) Phase II study of crizotinib in east Asian patients(pts)with ROS1-positive advanced non-small cell lung cancer(NSCLC). J Clin Oncol 34(15_suppl):9022CrossRef
15.
Planchard D, Besse B, Groen HJM et al (2016) Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. Lancet Oncol 17(7):984–993CrossRefPubMedPubMedCentral
16.
Yang JC, Sequist LV, Geater SL et al (2015) Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol 16(7):830–838CrossRefPubMed
17.
Inoue A, Kobayashi K, Usui K et al (2009) First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy. J Clin Oncol 27(9):1394–1400CrossRefPubMed
18.
Iwama E, Goto Y, Murakami H et al (2017) Alectinib for patients with ALK rearrangement-positive non-small cell lung cancer and a poor performance status (Lung Oncology Group in Kyushu 1401). J Thorac Oncol 12(7):1161–1166CrossRefPubMed
19.
Reck M, Rodriguez-Abreu D, Robinson AG et al (2016) KEYNOTE-024 investigators. pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med 375(19):1823–1833CrossRefPubMed
20.
Gandhi L, Rodríguez-Abreu D, Gadgeel S et al (2018) KEYNOTE-189 investigators. pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med 378(22):2078–2092CrossRefPubMed
21.
Socinski MA, Jotte RM, Cappuzzo F et al (2018) IMpower150 Study Group. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med 378(24):2288–2301CrossRefPubMed
22.
Paz-Ares LG, Luft A, Tafreshi A et al (2018) Phase 3 study of carboplatin-paclitaxel/nab-paclitaxel (Chemo)with or without pembrolizumab(Pembro)for patients (Pts)with metastatic squamous(Sq)non-small cell lung cancer (NSCLC). J Clin Oncol. 2018(suppl; abstr 105):36
23.
Jotte RM, Cappuzzo F, Vynnychenko I et al (2018) IMpower131: primary PFS and safety analysis of a randomized phase III study of atezolizumab + carboplatin + paclitaxel or nab-paclitaxel vs carboplatin + nab-paclitaxel as IL therapy in advanced squamous NSCLC. J Clin Oncol 2018(suppl; abstr LBA9000):36
24.
Rosell R, Moran T, Queralt C et al (2009) Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 361(10):958–967CrossRefPubMed
25.
Kris MG, Johnson BE, Berry LD et al (2014) Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA 311(19):1998–2006CrossRefPubMedPubMedCentral
26.
Sequist LV, Yang JC, Yamamoto N et al (2013) Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol 31(27):3327–3334CrossRefPubMed
27.
Planchard D, Smit EF, Groen HJM et al (2017) Dabrafenib plus trametinib in patients with previously untreated BRAF (V600E)-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial. Lancet Oncol 18(10):1307–1316CrossRefPubMed
28.
Maemondo M, Minegishi Y, Inoue A et al (2012) First-line gefitinib in patients aged 75 or older with advanced non-small cell lung cancer harboring epidermal growth factor receptor mutations: NEJ 003 study. J Thorac Oncol 7(9):1417–1422CrossRefPubMed
29.
Goto K, Nishio M, Yamamoto N et al (2013) A prospective, phase II, open-label study(JO22903)of first-line erlotinib in Japanese patients with epidermal growth factor receptor(EGFR)mutation-positive advanced non-small-cell lung cancer(NSCLC). Lung Cancer 82(1):109–114CrossRefPubMed
30.
Mitsudomi T, Morita S, Yatabe Y et al (2012) Updated overall survival results of WJTOG 3405, a randomized phase III trial comparing gefitinib(G)with cisplatin plus docetaxel(CD)as the first-line treatment for patients with non-small cell lung cancer harboring mutations of the epidermal growth factor receptor(EGFR). J Clin Oncol 30(15_suppl):7521
31.
Inoue A, Kobayashi K, Maemondo M et al (2013) Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naive non-small cell lung cancer with sensitive EGFR gene mutations(NEJ002). Ann Oncol 24(1):54–59CrossRefPubMed
32.
Inoue A, Yoshida K, Morita S et al (2016) Characteristics and overall survival of EGFR mutation-positive non-small cell lung cancer treated with EGFR tyrosine kinase inhibitors: a retrospective analysis for 1660 Japanese patients. Jpn J Clin Oncol 46(5):462–467CrossRefPubMedPubMedCentral
33.
Socinski MA, Jotte RM, Cappuzzo F et al (2018) Overall survival(OS)analysis of IMpower150, a randomized Ph 3 study of atezolizumab(atezo) + chemotherapy(chemo) ± bevacizumab(bev)vs chemo + bev in 1L nonsquamous(NSQ)NSCLC. J Clin Oncol 2018(suppl; abstr 9002):36
34.
Lee CK, Man J, Lord S et al (2017) Checkpoint inhibitors in metastatic EGFR-mutated non-small cell lung cancer—a meta-analysis. J Thorac Oncol 12(2):403–407CrossRefPubMed
35.
Gainor JF, Shaw AT, Sequist LV et al (2016) EGFR mutations and ALK rearrangements are associated with low response rates to PD-1 pathway blockade in non-small cell lung cancer: a retrospective analysis. Clin Cancer Res 22(18):4585–4593CrossRefPubMedPubMedCentral
36.
Oizumi S, Kobayashi K, Inoue A et al (2012) Quality of life with gefitinib in patients with EGFR-mutated non-small cell lung cancer: quality of life analysis of North East Japan Study Group 002 Trial. Oncologist 17(6):863–870CrossRefPubMedPubMedCentral
37.
Soria JC, Ohe Y, Vansteenkiste J, FLAURA investigators et al (2018). Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med 378(2):113–125CrossRefPubMed
38.
Wu YL, Cheng Y, Zhou X et al (2017) Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer(ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol 18(11):1454–1466CrossRefPubMed
39.
Mok TS, Cheng Y, Zhou X et al (2018) Improvement in overall survival in a randomized study that compared dacomitinib with gefitinib in patients with advanced non-small-cell lung cancer and EGFR-activating mutations. J Clin Oncol 36(22):2244–2250CrossRefPubMed
40.
Yang JJ, Zhou Q, Yan HH et al (2017) A phase III randomised controlled trial of erlotinib vs gefitinib in advanced non-small cell lung cancer with EGFR mutations. Br J Cancer 116(5):568–574CrossRefPubMedPubMedCentral
41.
Park K, Tan EH, O’Byrne K et al (2016) Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer(LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol 17(5):577–589CrossRefPubMed
42.
Furuya N, Fukuhara T, Saito H et al (2018) Phase III study comparing bevacizumab plus erlotinib to erlotinib in patients with untreated NSCLC harboring activating EGFR mutations: NEJ026. 2018 ASCO annual meeting. J Clin Oncol 36:9006CrossRef
43.
Seto T, Kato T, Nishio M et al (2014) Erlotinib alone or with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harbouring EGFR mutations(JO25567): an open-label, randomised, multicentre, phase 2 study. Lancet Oncol 15(11):1236–1244CrossRefPubMed
44.
Yamamoto N, Seto T, Nishio M et al (2018) Erlotinib plus bevacizumab(EB)versus erlotinib alone(E)as first-line treatment for advanced EGFR mutation-positive non-squamous non-small-cell lung cancer(NSCLC): Survival follow-up results of JO25567. 2018 ASCO annual meeting. J Clin Oncol 36:9007CrossRef
45.
Nakamura A, Inoue A, Morita S et al (2018) Phase III study comparing gefitinib monotherapy(G)to combination therapy with gefitinib, carboplatin, and pemetrexed(GCP)for untreated patients(pts)with advanced non-small cell lung cancer(NSCLC)with EGFR mutations(NEJ009). 2018 ASCO annual meeting. J Clin Oncol 36:9005CrossRef
46.
Inoue A, Kobayashi K, Usui K, North East Japan Gefitinib Study Group et al (2009) First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy. J Clin Oncol 27(9):1394–1400CrossRefPubMed
47.
Kudoh S, Kato H, Nishiwaki Y et al (2008) Interstitial lung disease in Japanese patients with lung cancer: a cohort and nested case-control study. Am J Respir Crit Care Med 177(12):1348–1357CrossRefPubMed
48.
Ando M, Okamoto I, Yamamoto N et al (2006) Predictive factors for interstitial lung disease, antitumor response, and survival in non-small-cell lung cancer patients treated with gefitinib. J Clin Oncol 24(16):2549–2556CrossRefPubMed
49.
Beau-Faller M, Prim N, Ruppert AM et al (2014) Rare EGFR exon 18 and exon 20 mutations in non-small-cell lung cancer on 10 117 patients: a multicentre observational study by the French ERMETIC-IFCT network. Ann Oncol 25(1):126–131CrossRefPubMed
50.
Wu JY, Yu CJ, Chang YC et al (2011) Effectiveness of tyrosine kinase inhibitors on“uncommon”epidermal growth factor receptor mutations of unknown clinical significance in non-small cell lung cancer. Clin Cancer Res 17(11):3812–3821CrossRefPubMed
51.
Yasuda H, Kobayashi S, Costa DB (2012) EGFR exon 20 insertion mutations in non-small-cell lung cancer: preclinical data and clinical implications. Lancet Oncol 13(1):e23–e31CrossRefPubMed
52.
Ramalingam SS, Yang JC, Lee CK et al (2018) Osimertinib As First-Line Treatment of EGFR Mutation-Positive Advanced Non-Small-Cell Lung Cancer. J Clin Oncol 36(9):841–849CrossRefPubMed
53.
Mok TS, Wu Y-L, Ahn M-J et al (2017) Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med 376(7):629–640CrossRefPubMed
54.
Solomon BJ, Mok T, Kim DW et al (2014) PROFILE 1014 Investigators. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med 371(23):2167–2177CrossRefPubMed
55.
Soria JC, Tan DSW, Chiari R et al (2017) First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer(ASCEND-4): a randomised, open-label, phase 3 study. Lancet 389(10072):917–929CrossRefPubMed
56.
Hida T, Nokihara H, Kondo M et al (2017) Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer(J-ALEX): an open-label, randomised phase 3 trial. Lancet 390(10089):29–39CrossRefPubMed
57.
Takiguchi Y, Hida T, Nokihara H et al (2017) Updated efficacy and safety of the j-alex study comparing alectinib (ALC) with crizotinib(CRZ)in ALK-inhibitor naïve ALK fusion positive non-small cell lung cancer(ALK + NSCLC). J Clin Oncol 35(15 suppl):9064CrossRef
58.
Peters S, Camidge DR, Shaw AT et al (2017) Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med 377(9):829–838CrossRefPubMed
59.
Ou SH, Ahn JS, De Petris L et al (2016) Alectinib in crizotinib-refractory ALK-rearranged non-small-cell lung cancer: a phase II global study. J Clin Oncol 34(7):661–668CrossRefPubMed
60.
Gadgeel SM, Gandhi L, Riely GJ et al (2014) Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study. Lancet Oncol 15(10):1119–1128CrossRefPubMed
61.
Shaw AT, Gandhi L, Gadgeel S et al (2016) Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial. Lancet Oncol 17(2):234–242CrossRefPubMed
62.
Hotta K, Hida T, Nakagawa K et al (2015) Updated data from JP28927 study of alectinib in ALK + NSCLC patients with or without history of ALK inhibitor treatment. J Thorac Oncol 10(9 suppl 2):S648
63.
64.
Crinò L, Ahn MJ, De Martins F et al (2016) Multicenter phase II study of whole-body and intracranial activity with ceritinib in patients with ALK-rearranged non-small-cell lung cancer previously treated with chemotherapy and crizotinib: results from ASCEND-2. J Clin Oncol 34(24):2866–2873CrossRefPubMed
65.
Shaw AT, Kim TM, Crinò L et al (2017) Ceritinib versus chemotherapy in patients with ALK-rearranged non-small-cell lung cancer previously given chemotherapy and crizotinib (ASCEND-5): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol 18(7):874–886CrossRefPubMed
66.
Nishio M, Murakami H, Horiike A et al (2015) Phase I study of ceritinib (LDK378) in Japanese patients with advanced, anaplastic lymphoma kinase-rearranged non-small-cell lung cancer or other tumors. J Thorac Oncol 10(7):1058–1066CrossRefPubMedPubMedCentral
67.
Shaw AT, Felip E, Bauer TM et al (2017) Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol 18(12):1590–1599CrossRefPubMedPubMedCentral
68.
Besse B, Solomon BJ, Felip E et al (2018) Lorlatinib in patients(Pts)with previously treated ALK + advanced non-small cell lung cancer(NSCLC): updated efficacy and safety. 2018 ASCO annual meeting. J Clin Oncol 36:9032CrossRef
69.
Shukuya T, Takahashi T, Kaira R et al (2011) Efficacy of gefitinib for non-adenocarcinoma non-small-cell lung cancer patients harboring epidermal growth factor receptor mutations: a pooled analysis of published reports. Cancer Sci 102(5):1032–1037CrossRefPubMed
70.
Yamada K, Takayama K, Kawakami S et al (2013) Phase II trial of erlotinib for Japanese patients with previously treated non-small-cell lung cancer harboring EGFR mutations: results of Lung Oncology Group in Kyushu (LOGiK0803). Jpn J Clin Oncol 43(6):629–635CrossRefPubMed
71.
Yamada K, Aono H, Hosomi Y et al (2015) A prospective, multicentre phase II trial of low-dose erlotinib in non-small cell lung cancer patients with EGFR mutations pretreated with chemotherapy: thoracic Oncology Research Group 0911. Eur J Cancer 51(14):1904–1910CrossRefPubMed
72.
Hata A, Katakami N, Yoshioka H (2013) How sensitive are epidermal growth factor receptor-tyrosine kinase inhibitors for squamous cell carcinoma of the lung harboring EGFR gene-sensitive mutations? J Thorac Oncol 8(1):89–95CrossRefPubMed
73.
Xu J, Zhang Y, Jin B et al (2016) Efficacy of EGFR tyrosine kinase inhibitors for non-adenocarcinoma lung cancer patients harboring EGFR-sensitizing mutations in China. J Cancer Res Clin Oncol 142(6):1325–1330CrossRefPubMed
74.
Reck M, Rodríguez-Abreu D, Robinson AG et al (2016) Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med 375(19):1823–1833CrossRefPubMed
75.
Ohe Y, Ohashi Y, Kubota K et al (2007) Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: four-Arm Cooperative Study in Japan. Ann Oncol 18(2):317–323CrossRefPubMed
76.
Scagliotti GV, Parikh P, von Pawel J et al (2008) Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 26(21):3543–3551CrossRefPubMed
77.
Grønberg BH, Bremnes RM, Fløtten O et al (2009) Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol 27(19):3217–3224CrossRefPubMed
78.
Rodrigues-Pereira J, Kim JH, Magallanes M et al (2011) A randomized phase 3 trial comparing pemetrexed/carboplatin and docetaxel/carboplatin as first-line treatment for advanced, nonsquamous non-small cell lung cancer. J Thorac Oncol 6(11):1907–1914CrossRefPubMed
79.
Zinner RG, Obasaju CK, Spigel DR et al (2015) PRONOUNCE: randomized, open-label, phase III study of first-line pemetrexed + carboplatin followed by maintenance pemetrexed versus paclitaxel + carboplatin + bevacizumab followed by maintenance bevacizumab in patients ith advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol 10(1):134–142CrossRefPubMed
80.
Patel JD, Socinski MA, Garon EB et al (2013) PointBreak: a randomized phase III study of pemetrexed plus carboplatin and bevacizumab followed by maintenance pemetrexed and bevacizumab versus paclitaxel plus carboplatin and bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. J Clin Oncol 31(34):4349–4357CrossRefPubMedPubMedCentral
81.
Shukuya T, Yamanaka T, Seto T et al (2015) Nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung(WJOG5208L): a randomised, open-label, phase 3 trial. Lancet Oncol 16(16):1630–1638CrossRefPubMed
82.
Okamoto I, Yoshioka H, Morita S et al (2010) Phase III trial comparing oral S-1 plus carboplatin with paclitaxel plus carboplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer: results of a west Japan oncology group study. J Clin Oncol 28(36):5240–5246CrossRefPubMed
83.
Kubota K, Sakai H, Katakami N et al (2015) A randomized phase III trial of oral S-1 plus cisplatin versus docetaxel plus cisplatin in Japanese patients with advanced non-small-cell lung cancer: TCOG0701 CATS trial. Ann Oncol 26(7):1401–1408CrossRefPubMedPubMedCentral
84.
Socinski MA, Bondarenko I, Karaseva NA et al (2012) Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol 30(17):2055–2062CrossRefPubMed
85.
Maione P, Perrone F, Gallo C et al (2005) Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancer receiving chemotherapy: a prognostic analysis of the multicenter Italian lung cancer in the elderly study. J Clin Oncol 23(28):6865–6872CrossRefPubMed
86.
Hesketh PJ, Lilenbaum RC, Chansky K et al (2007) Chemotherapy in patients> or = 80 with advanced non-small cell lung cancer: combined results from SWOG 0027 and LUN 6. J Thorac Oncol 2(6):494–498CrossRefPubMed
87.
The Elderly Lung Cancer Vinorelbine Italian Study Group (1999) Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 91(1):66–72CrossRef
88.
Gridelli C, Perrone F, Gallo C et al (2003) Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study(MILES) phase III randomized trial. J Natl Cancer Inst 95(5):362–372CrossRefPubMed
89.
Kudoh S, Takeda K, Nakagawa K et al (2006) Phase III study of docetaxel compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer: results of the West Japan Thoracic Oncology Group Trial(WJTOG 9904). J Clin Oncol 24(22):3657–3663CrossRefPubMed
90.
Abe T, Takeda K, Ohe Y et al (2015) Randomized phase III trial comparing weekly docetaxel plus cisplatin versus docetaxel monotherapy every 3 weeks in elderly patients with advanced non-small-cell lung cancer: the intergroup trial JCOG0803/WJOG4307L. J Clin Oncol 33(6):575–581CrossRefPubMed
91.
Quoix E, Zalcman G, Oster JP et al (2011) Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet 378(9796):1079–1088CrossRefPubMed
92.
Gridelli C, Ardizzoni A, Le Chevalier T et al (2004) Treatment of advanced non-small-cell lung cancer patients with ECOG performance status 2: results of an European Experts Panel. Ann Oncol 15(3):419–426CrossRefPubMed
93.
Lilenbaum RC, Herndon JE II, List MA et al (2005) Single-agent versus combination chemotherapy in advanced non-small-cell lung cancer: the cancer and leukemia group B(study 9730). J Clin Oncol 23(1):190–196CrossRefPubMed
94.
Langer C, Li S, Schiller J et al (2007) Randomized phase II trial of paclitaxel plus carboplatin or gemcitabine plus cisplatin in Eastern Cooperative Oncology Group performance status 2 non-small-cell lung cancer patients: ECOG 1599. J Clin Oncol 25(4):418–423CrossRefPubMed
95.
Kosmidis PA, Dimopoulos MA, Syrigos K et al (2007) Gemcitabine versus gemcitabine-carboplatin for patients with advanced non-small cell lung cancer and a performance status of 2: a prospective randomized phase II study of the Hellenic Cooperative Oncology Group. J Thorac Oncol 2(2):135–140CrossRefPubMed
96.
Zukin M, Barrios CH, Pereira JR et al (2013) Randomized phase III trial of single-agent pemetrexed versus carboplatin and pemetrexed in patients with advanced non-small-cell lung cancer and Eastern Cooperative Oncology Group performance status of 2. J Clin Oncol 31(23):2849–2853CrossRefPubMed
97.
von Plessen C, Bergman B, Andresen O et al (2006) Palliative chemotherapy beyond three courses conveys no survival or consistent quality-of-life benefits in advanced non-small-cell lung cancer. Br J Cancer 95(8):966–973CrossRef
98.
Park JO, Kim SW, Ahn JS et al (2007) Phase III trial of two versus four additional cycles in patients who are nonprogressive after two cycles of platinum-based chemotherapy in non small-cell lung cancer. J Clin Oncol 25(33):5233–5239CrossRefPubMed
99.
Rossi A, Chiodini P, Sun JM et al (2014) Six versus fewer planned cycles of first-line platinum-based chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual patient data. Lancet Oncol 15(11):1254–1262CrossRefPubMed
100.
Lima AB, Macedo LT, Sasse AD (2011) Addition of bevacizumab to chemotherapy in advanced non-small cell lung cancer: a systematic review and meta-analysis. PLoS One 6(8):e22681CrossRefPubMedPubMedCentral
101.
Soria JC, Mauguen A, Reck M et al (2013) Systematic review and meta-analysis of randomised, phase II/III trials adding bevacizumab to platinum-based chemotherapy as first-line treatment in patients with advanced non-small-cell lung cancer. Ann Oncol 24(1):20–30CrossRefPubMed
102.
Sandler AB, Schiller JH, Gray R et al (2009) Retrospective evaluation of the clinical and radiographic risk factors associated with severe pulmonary hemorrhage in first-line advanced, unresectable non-small-cell lung cancer treated with Carboplatin and Paclitaxel plus bevacizumab. J Clin Oncol 27(9):1405–1412CrossRefPubMedPubMedCentral
103.
Sandler A, Gray R, Perry MC et al (2006) Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 355(24):2542–2550CrossRefPubMed
104.
Reck M, von Pawel J, Zatloukal P et al (2010) Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial(AVAiL). Ann Oncol 21(9):1804–1809CrossRefPubMedPubMedCentral
105.
Niho S, Kunitoh H, Nokihara H et al (2012) Randomized phase II study of first-line carboplatin-paclitaxel with or without bevacizumab in Japanese patients with advanced non-squamous non-small-cell lung cancer. Lung Cancer 76(3):362–367CrossRefPubMed
106.
Zhou C, Wu YL, Chen G et al (2015) BEYOND: a randomized, double-blind, placebo-controlled, multicenter, phase III study of first-line carboplatin/paclitaxel plus bevacizumab or Placebo in Chinese Patients With Advanced or Recurrent Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol 33(19):2197–2204CrossRefPubMed
107.
Ramalingam SS, Dahlberg SE, Langer CJ et al (2008) Outcomes for elderly, advanced-stage non small-cell lung cancer patients treated with bevacizumab in combination with carboplatin and paclitaxel: analysis of Eastern Cooperative Oncology Group Trial 4599. J Clin Oncol 26(1):60–65CrossRefPubMed
108.
Langer CJ, Socinski MA, Patel JD et al (2016) Isolating the role of bevacizumab in elderly patients with previously untreated nonsquamous non-small cell lung Cancer: secondary analyses of the ECOG 4599 and pointbreak trials. Am J Clin Oncol 39(5):441–447CrossRefPubMed
109.
Wozniak AJ, Kosty MP, Jahanzeb M et al (2015) Clinical outcomes in elderly patients with advanced non-small cell lung cancer: results from ARIES, a bevacizumab observational cohort study. Clin Oncol (R Coll Radiol) 27(4):187–196CrossRef
110.
Laskin J, Crino L, Felip E et al (2012) Safety and efficacy of first-line bevacizumab plus chemotherapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer: safety of avastin in lung trial (MO19390). J Thorac Oncol 7(1):203–211CrossRefPubMed
111.
Johnson DH, Fehrenbacher L, Novotny WF et al (2004) Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 22(11):2184–2191CrossRefPubMed
112.
Paz-Ares LG, de Marinis F, Dediu M et al (2013) PARAMOUNT: final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol 31(23):2895–2902CrossRefPubMed
113.
Barlesi F, Scherpereel A, Gorbunova V et al (2014) Maintenance bevacizumab-pemetrexed after first-line cisplatin-pemetrexed-bevacizumab for advanced nonsquamous nonsmall-cell lung cancer: updated survival analysis of the AVAPERL(MO22089)randomized phase III trial. Ann Oncol 25(5):1044–1052CrossRefPubMed
114.
Ciuleanu T, Brodowicz T, Zielinski C et al (2009) Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet 374(9699):1432–1440CrossRefPubMed
115.
Cappuzzo F, Ciuleanu T, Stelmakh L et al (2010) Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol 11(6):521–529CrossRefPubMed
116.
Cicènas S, Geater SL, Petrov P et al (2016) Maintenance erlotinib versus erlotinib at disease progression in patients with advanced non-small-cell lung cancer who have not progressed following platinum-based chemotherapy (IUNO study). Lung Cancer 102:30–37CrossRefPubMed
117.
Lee SM, Khan I, Upadhyay S et al (2012) First-line erlotinib in patients with advanced non-small-cell lung cancer unsuitable for chemotherapy (TOPICAL): a double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 13(11):1161–1170CrossRefPubMedPubMedCentral
118.
Brahmer J, Reckamp KL, Baas P et al (2015) Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 373(2):123–135CrossRefPubMedPubMedCentral
119.
Borghaei H, Paz-Ares L, Horn L et al (2015) Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med 373(17):1627–1639CrossRefPubMedPubMedCentral
120.
Rittmeyer A, Barlesi F, Waterkamp D, OAK Study Group et al (2017) Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet 389(10066):255–265CrossRefPubMed
121.
Herbst RS, Baas P, Kim DW et al (2016) Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 387(10027):1540–1550CrossRefPubMed
122.
Fehrenbacher L, Spira A, Ballinger M, POPLAR Study Group et al (2016) Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet 387(10030):1837–1846CrossRefPubMed
123.
Fossella FV, DeVore R, Kerr RN et al (2000) Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol 18(12):2354–2362CrossRefPubMed
124.
Shepherd FA, Dancey J, Ramlau R et al (2000) Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18(10):2095–2103CrossRefPubMed
125.
Mukohara T, Takeda K, Miyazaki M et al (2001) Japanese experience with second-line chemotherapy with low-dose(60 mg/M2) docetaxel in patients with advanced non-small-cell lung cancer. Cancer Chemother Pharmacol 48(5):356–360CrossRefPubMed
126.
Hanna N, Shepherd FA, Fossella FV et al (2004) Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22(9):1589–1597CrossRefPubMed
127.
Scagliotti G, Hanna N, Fossella F et al (2009) The differential efficacy of pemetrexed according to NSCLC histology: a review of two phase III studies. Oncologist 14(3):253–263CrossRefPubMed
128.
Nokihara H, Lu S, Mok TSK et al (2017) Randomized controlled trial of S-1 versus docetaxel in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy (East Asia S-1 Trial in Lung Cancer). Ann Oncol 28(11):2698–2706CrossRefPubMedPubMedCentral
129.
Garon EB, Ciuleanu TE, Arrieta O et al (2014) Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet 384(9944):665–673CrossRefPubMed
130.
Yoh K, Hosomi Y, Kasahara K et al (2016) A randomized, double-blind, phase II study of ramucirumab plus docetaxel vs placebo plus docetaxel in Japanese patients with stage IV non-small cell lung cancer after disease progression on platinum-based therapy. Lung Cancer 99:186–193CrossRefPubMed
131.
Shepherd FA, Rodrigues Pereira J, Ciuleanu T et al (2005) Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353(2):123–132CrossRefPubMed
132.
Garassino MC, Martelli O, Broggini M et al (2013) Erlotinib versus docetaxel as second-line treatment of patients with advanced non-small-cell lung cancer and wild-type EGFR tumours (TAILOR): a randomised controlled trial. Lancet Oncol 14(10):981–988CrossRefPubMed
133.
Kawaguchi T, Ando M, Asami K et al (2014) Randomized phase III trial of erlotinib versus docetaxel as second- or third-line therapy in patients with advanced non-small-cell lung cancer: Docetaxel and Erlotinib Lung Cancer Trial (DELTA). J Clin Oncol 32(18):1902–1908CrossRefPubMed
Metadata
Title
The Japanese Lung Cancer Society Guideline for non-small cell lung cancer, stage IV
Authors
Hiroaki Akamatsu
Kiichiro Ninomiya
Hirotsugu Kenmotsu
Masahiro Morise
Haruko Daga
Yasushi Goto
Toshiyuki Kozuki
Satoru Miura
Takaaki Sasaki
Akihiro Tamiya
Shunsuke Teraoka
Yukari Tsubata
Hiroshige Yoshioka
Yoshihiro Hattori
Chiyo K. Imamura
Yuki Katsuya
Reiko Matsui
Yuji Minegishi
Hidenori Mizugaki
Kaname Nosaki
Yusuke Okuma
Setsuko Sakamoto
Takashi Sone
Kentaro Tanaka
Shigeki Umemura
Takeharu Yamanaka
Shinsuke Amano
Kazuo Hasegawa
Satoshi Morita
Kazuko Nakajima
Makoto Maemondo
Takashi Seto
Nobuyuki Yamamoto
Publication date
01-07-2019
Publisher
Springer Singapore
Published in
International Journal of Clinical Oncology / Issue 7/2019
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI
https://doi.org/10.1007/s10147-019-01431-z

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