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Published in: Surgery Today 7/2018

01-07-2018 | Original Article

Adjuvant vinorelbine and cisplatin after complete resection of stage II and III non-small cell lung cancer: long-term follow-up of our study of Japanese patients

Authors: Makoto Sonobe, Masatsugu Hamaji, Hideki Motoyama, Toshi Menju, Akihiro Aoyama, Toyofumi F. Chen-Yoshikawa, Toshihiko Sato, Hiroshi Date

Published in: Surgery Today | Issue 7/2018

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Abstract

Purpose

We reported previously a phase II study of adjuvant chemotherapy consisting of four cycles of vinorelbine (25 mg/m2) and cisplatin (40 mg/m2), given on days 1 and 8, every 4 weeks, to Japanese patients with completely resected stage II or III non-small cell lung cancer (NSCLC; UMIN 000005055). However, the follow-up was too short for us to evaluate a definitive 5-year overall survival rate and after-effects.

Methods

Between December 2006 and January 2011, 60 patients were enrolled in this study. We analyzed relapse-free and overall survival, long-lasting adverse effects, the influence of treatment on recurrent tumors, and the development of a second primary cancer, in relation with the regimen.

Results

After a median follow-up period of 95.8 months, the 5-year relapse-free and overall survival rates were 51.7 and 76.7%, respectively. Neuralgia developed in one patient and this was the only case of a long-lasting adverse effect. Recurrence developed in 31 patients, 29 of whom received intensive treatment. Although 16 s (or more) primary neoplasms developed among 13 patients, these were common carcinomas in Japan and did not include sarcoma or hematologic malignancies.

Conclusion

Adjuvant vinorelbine and cisplatin chemotherapy showed encouraging relapse-free and overall survival rates, and long-term safety in Japanese patients with resected NSCLC.
Literature
1.
go back to reference Sawabata N, Miyaoka E, Asamura H, Nakanishi Y, Eguchi K, Mori M, et al. Japanese Joint Committee for Lung Cancer Registration. Japanese lung cancer registry study of 11,663 surgical cases in 2004: demographic and prognosis changes over decade. J Thorac Oncol. 2011;6:1229–35.CrossRefPubMed Sawabata N, Miyaoka E, Asamura H, Nakanishi Y, Eguchi K, Mori M, et al. Japanese Joint Committee for Lung Cancer Registration. Japanese lung cancer registry study of 11,663 surgical cases in 2004: demographic and prognosis changes over decade. J Thorac Oncol. 2011;6:1229–35.CrossRefPubMed
2.
go back to reference Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J, International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med. 2004; 350:351–60.CrossRefPubMed Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J, International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med. 2004; 350:351–60.CrossRefPubMed
3.
go back to reference Winton T, Livingston R, Johnson D, Rigas J, Johnston M, Butts C, et al. Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer. N Engl J Med. 2005;352:2589–97.CrossRefPubMed Winton T, Livingston R, Johnson D, Rigas J, Johnston M, Butts C, et al. Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer. N Engl J Med. 2005;352:2589–97.CrossRefPubMed
4.
go back to reference Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzáles-Larriba JL, et al. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006;7:719–27.CrossRefPubMed Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzáles-Larriba JL, et al. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006;7:719–27.CrossRefPubMed
5.
go back to reference Pignon JP, Tribodet H, Scagliotti GV, Douillard JY, Shepherd FA, Stephens RJ, et al. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552–9.CrossRefPubMed Pignon JP, Tribodet H, Scagliotti GV, Douillard JY, Shepherd FA, Stephens RJ, et al. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552–9.CrossRefPubMed
6.
go back to reference Douillard JY, Tribodet H, Aubert D, Shepherd FA, Rosell R, Ding K, et al. Adjuvant cisplatin and vinorelbine for completely resected non-small cell lung cancer: subgroup analysis of the Lung Adjuvant Cisplatin Evaluation. J Thorac Oncol. 2010;5:220–8.CrossRefPubMed Douillard JY, Tribodet H, Aubert D, Shepherd FA, Rosell R, Ding K, et al. Adjuvant cisplatin and vinorelbine for completely resected non-small cell lung cancer: subgroup analysis of the Lung Adjuvant Cisplatin Evaluation. J Thorac Oncol. 2010;5:220–8.CrossRefPubMed
7.
go back to reference Wada H, Hitomi S, Teramatsu T. Adjuvant chemotherapy after complete resection in non-small-cell lung cancer. West Japan Study Group for Lung Cancer Surgery. J Clin Oncol. 1996;14:1048–54.CrossRefPubMed Wada H, Hitomi S, Teramatsu T. Adjuvant chemotherapy after complete resection in non-small-cell lung cancer. West Japan Study Group for Lung Cancer Surgery. J Clin Oncol. 1996;14:1048–54.CrossRefPubMed
8.
go back to reference Tada H, Tsuchiya R, Ichinose Y, Koike T, Nishizawa N, Nagai K, et al. A randomized trial comparing adjuvant chemotherapy versus surgery alone for completely resected pN2 non-small cell lung cancer (JCOG9304). Lung Cancer. 2004;43:167–73.CrossRefPubMed Tada H, Tsuchiya R, Ichinose Y, Koike T, Nishizawa N, Nagai K, et al. A randomized trial comparing adjuvant chemotherapy versus surgery alone for completely resected pN2 non-small cell lung cancer (JCOG9304). Lung Cancer. 2004;43:167–73.CrossRefPubMed
9.
go back to reference Sonobe M, Okubo K, Teramukai S, Yanagihara K, Sato M, Sato T, et al. Phase II study of adjuvant vinorelbine and cisplatin in Japanese patients with completely resected stage II and III non-small cell lung cancer. Cancer Chemother Pharmacol. 2014;74:1199–206.CrossRef Sonobe M, Okubo K, Teramukai S, Yanagihara K, Sato M, Sato T, et al. Phase II study of adjuvant vinorelbine and cisplatin in Japanese patients with completely resected stage II and III non-small cell lung cancer. Cancer Chemother Pharmacol. 2014;74:1199–206.CrossRef
10.
go back to reference Arriagada R, Dunant A, Pignon JP, Bergman B, Chabowski M, Grunenwald D, et al. Long-term results of the international adjuvant lung cancer trial evaluating adjuvant Cisplatin-based chemotherapy in resected lung cancer. J Clin Oncol. 2010;28:35–42.CrossRefPubMed Arriagada R, Dunant A, Pignon JP, Bergman B, Chabowski M, Grunenwald D, et al. Long-term results of the international adjuvant lung cancer trial evaluating adjuvant Cisplatin-based chemotherapy in resected lung cancer. J Clin Oncol. 2010;28:35–42.CrossRefPubMed
11.
go back to reference Mountain CF. Revisions in the international system for staging lung cancer. Chest. 1997;111:1710–17.CrossRefPubMed Mountain CF. Revisions in the international system for staging lung cancer. Chest. 1997;111:1710–17.CrossRefPubMed
12.
go back to reference Antakli T, Schaefer RF, Rutherford JE, Read RC. Second primary lung cancer. Ann Thorac Surg. 1995;59:863–6.CrossRefPubMed Antakli T, Schaefer RF, Rutherford JE, Read RC. Second primary lung cancer. Ann Thorac Surg. 1995;59:863–6.CrossRefPubMed
13.
go back to reference Goldstraw P, Crowley J, Chansky K, Giroux DJ, Groome PA, Rami-Porta R, et al. The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol 2007;2:706–14.CrossRef Goldstraw P, Crowley J, Chansky K, Giroux DJ, Groome PA, Rami-Porta R, et al. The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol 2007;2:706–14.CrossRef
15.
go back to reference Shukuya T, Takahashi T, Tamiya A, Ono A, Igawa S, Tsuya A, et al. Evaluation of the safety and compliance of 3-week cycles of vinorelbine on days 1 and 8 and cisplatin on day 1 as adjuvant chemotherapy in Japanese patients with completely resected pathological stage IB to IIIA non-small cell lung cancer: a retrospective study. Jpn J Clin Oncol. 2009;39:158–62. Shukuya T, Takahashi T, Tamiya A, Ono A, Igawa S, Tsuya A, et al. Evaluation of the safety and compliance of 3-week cycles of vinorelbine on days 1 and 8 and cisplatin on day 1 as adjuvant chemotherapy in Japanese patients with completely resected pathological stage IB to IIIA non-small cell lung cancer: a retrospective study. Jpn J Clin Oncol. 2009;39:158–62.
16.
go back to reference Sonobe M, Nakagawa M, Takenaka K, Katakura H, Adachi M, Yanagihara K, et al. Influence of epidermal growth factor receptor (EGFR) gene mutations on the expression of EGFR, phosphoryl-Akt, and phosphoryl-MAPK, and on the prognosis of patients with non-small cell lung cancer. J Surg Oncol. 2007;95:63–9.CrossRef Sonobe M, Nakagawa M, Takenaka K, Katakura H, Adachi M, Yanagihara K, et al. Influence of epidermal growth factor receptor (EGFR) gene mutations on the expression of EGFR, phosphoryl-Akt, and phosphoryl-MAPK, and on the prognosis of patients with non-small cell lung cancer. J Surg Oncol. 2007;95:63–9.CrossRef
17.
go back to reference Sonobe M, Kobayashi M, Ishikawa M, Kikuchi R, Nakayama E, Takahashi T, et al. Impact of KRAS and EGFR gene mutations on recurrence and survival in patients with surgically resected lung adenocarcinomas. Ann Surg Oncol. 2012;19(Suppl 3):S347-54.PubMed Sonobe M, Kobayashi M, Ishikawa M, Kikuchi R, Nakayama E, Takahashi T, et al. Impact of KRAS and EGFR gene mutations on recurrence and survival in patients with surgically resected lung adenocarcinomas. Ann Surg Oncol. 2012;19(Suppl 3):S347-54.PubMed
18.
go back to reference Mitsudomi T, Morita S, Yatabe Y, Negoro S, Okamoto I, Tsurutani J, et al. 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. 2010;11:121–8.CrossRefPubMed Mitsudomi T, Morita S, Yatabe Y, Negoro S, Okamoto I, Tsurutani J, et al. 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. 2010;11:121–8.CrossRefPubMed
19.
go back to reference Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010;362:2380–8.CrossRefPubMed Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010;362:2380–8.CrossRefPubMed
20.
go back to reference Yokoyama Y, Sonobe M, Yamada T, Sato M, Menju T, Aoyama A, et al. Gefitinib treatment in patients with postoperative recurrent non-small-cell lung cancer harboring epidermal growth factor receptor gene mutations. Int J Clin Oncol. 2015;20:1122–9.CrossRefPubMed Yokoyama Y, Sonobe M, Yamada T, Sato M, Menju T, Aoyama A, et al. Gefitinib treatment in patients with postoperative recurrent non-small-cell lung cancer harboring epidermal growth factor receptor gene mutations. Int J Clin Oncol. 2015;20:1122–9.CrossRefPubMed
21.
go back to reference Niibe Y, Hayakawa K. Oligometastases and oligo-recurrence: the new era of cancer therapy. Jpn J Clin Oncol. 2010;40:107–11. Niibe Y, Hayakawa K. Oligometastases and oligo-recurrence: the new era of cancer therapy. Jpn J Clin Oncol. 2010;40:107–11.
22.
go back to reference Yano T, Haro A, Yoshida T, Morodomi Y, Ito K, Shikada Y, et al. Prognostic impact of local treatment against postoperative oligometastases in non-small cell lung cancer. J Surg Oncol. 2010;102:852–5.CrossRefPubMed Yano T, Haro A, Yoshida T, Morodomi Y, Ito K, Shikada Y, et al. Prognostic impact of local treatment against postoperative oligometastases in non-small cell lung cancer. J Surg Oncol. 2010;102:852–5.CrossRefPubMed
23.
go back to reference Sonobe M, Yamada T, Sato M, Menju T, Aoyama A, Sato T, et al. Identification of subsets of patients with favorable prognosis after recurrence in completely resected non-small cell lung cancer. Ann Surg Oncol. 2014;21:2546–54.CrossRefPubMed Sonobe M, Yamada T, Sato M, Menju T, Aoyama A, Sato T, et al. Identification of subsets of patients with favorable prognosis after recurrence in completely resected non-small cell lung cancer. Ann Surg Oncol. 2014;21:2546–54.CrossRefPubMed
24.
go back to reference Iwamoto Y, Mitsudomi T, Sakai K, Yamanaka T, Yoshioka H, Takahama M, et al. Randomized phase II study of adjuvant chemotherapy with long-term S-1 versus cisplatin + S-1 in completely resected stage II–IIIA non-small cell lung cancer. Clin Cancer Res. 2015;21:5245–52.CrossRefPubMed Iwamoto Y, Mitsudomi T, Sakai K, Yamanaka T, Yoshioka H, Takahama M, et al. Randomized phase II study of adjuvant chemotherapy with long-term S-1 versus cisplatin + S-1 in completely resected stage II–IIIA non-small cell lung cancer. Clin Cancer Res. 2015;21:5245–52.CrossRefPubMed
26.
27.
go back to reference Rotolo F, Dunant A, Le Chevalier T, Pignon JP, Arriagada R. IALT Collaborative Group. Adjuvant cisplatin-based chemotherapy in nonsmall-cell lung cancer: new insights into the effect on failure type via a multistate approach. Ann Oncol. 2014; 25:2162–6.CrossRefPubMed Rotolo F, Dunant A, Le Chevalier T, Pignon JP, Arriagada R. IALT Collaborative Group. Adjuvant cisplatin-based chemotherapy in nonsmall-cell lung cancer: new insights into the effect on failure type via a multistate approach. Ann Oncol. 2014; 25:2162–6.CrossRefPubMed
29.
go back to reference Travis LB, Fosså SD, Schonfeld SJ, McMaster ML, Lynch CF, Storm H, et al. Second cancers among 40,576 testicular cancer patients: focus on long-term survivors. J Natl Cancer Inst. 2005;97:1354–65.CrossRefPubMed Travis LB, Fosså SD, Schonfeld SJ, McMaster ML, Lynch CF, Storm H, et al. Second cancers among 40,576 testicular cancer patients: focus on long-term survivors. J Natl Cancer Inst. 2005;97:1354–65.CrossRefPubMed
30.
go back to reference van den Belt-Dusebout AW, de Wit R, Gietema JA, Horenblas S, Louwman MW, Ribot JG, et al. Treatment-specific risks of second malignancies and cardiovascular disease in 5-year survivors of testicular cancer. J Clin Oncol. 2007;25:4370–8.CrossRefPubMed van den Belt-Dusebout AW, de Wit R, Gietema JA, Horenblas S, Louwman MW, Ribot JG, et al. Treatment-specific risks of second malignancies and cardiovascular disease in 5-year survivors of testicular cancer. J Clin Oncol. 2007;25:4370–8.CrossRefPubMed
31.
go back to reference Johnson BE. Second lung cancers in patients after treatment for an initial lung cancer. J Natl Cancer Inst. 1998;90:1335–45.CrossRefPubMed Johnson BE. Second lung cancers in patients after treatment for an initial lung cancer. J Natl Cancer Inst. 1998;90:1335–45.CrossRefPubMed
32.
go back to reference Surapaneni R, Singh P, Rajagopalan K, Hageboutros A. Stage I lung cancer survivorship: risk of second malignancies and need for individualized care plan. J Thorac Oncol. 2012;7:1252–6.CrossRefPubMed Surapaneni R, Singh P, Rajagopalan K, Hageboutros A. Stage I lung cancer survivorship: risk of second malignancies and need for individualized care plan. J Thorac Oncol. 2012;7:1252–6.CrossRefPubMed
33.
go back to reference Hamaji M, Allen MS, Cassivi SD, Deschamps C, Nichols FC, Wigle DA, et al. Surgical treatment of metachronous second primary lung cancer after complete resection of non-small cell lung cancer. J Thorac Cardiovasc Surg. 2013;145:683–90.CrossRef Hamaji M, Allen MS, Cassivi SD, Deschamps C, Nichols FC, Wigle DA, et al. Surgical treatment of metachronous second primary lung cancer after complete resection of non-small cell lung cancer. J Thorac Cardiovasc Surg. 2013;145:683–90.CrossRef
34.
go back to reference Hori M, Matsuda T, Shibata A, Katanoda K, Sobue T, Nishimoto H, Japan Cancer Surveillance Research Group. Cancer incidence and incidence rates in Japan in 2009: a study of 32 population-based cancer registries for the Monitoring of Cancer Incidence in Japan (MCIJ) project. Jpn J Clin Oncol. 2015;45:884–91. Hori M, Matsuda T, Shibata A, Katanoda K, Sobue T, Nishimoto H, Japan Cancer Surveillance Research Group. Cancer incidence and incidence rates in Japan in 2009: a study of 32 population-based cancer registries for the Monitoring of Cancer Incidence in Japan (MCIJ) project. Jpn J Clin Oncol. 2015;45:884–91.
Metadata
Title
Adjuvant vinorelbine and cisplatin after complete resection of stage II and III non-small cell lung cancer: long-term follow-up of our study of Japanese patients
Authors
Makoto Sonobe
Masatsugu Hamaji
Hideki Motoyama
Toshi Menju
Akihiro Aoyama
Toyofumi F. Chen-Yoshikawa
Toshihiko Sato
Hiroshi Date
Publication date
01-07-2018
Publisher
Springer Singapore
Published in
Surgery Today / Issue 7/2018
Print ISSN: 0941-1291
Electronic ISSN: 1436-2813
DOI
https://doi.org/10.1007/s00595-018-1646-7

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