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BMC Cancer
Published in: BMC Cancer 1/2013

Open Access 01-12-2013 | Research article

Multicenter phase II study of weekly docetaxel, cisplatin, and S-1 (TPS) induction chemotherapy for locally advanced squamous cell cancer of the head and neck

Authors: Woo Kyun Bae, Jun Eul Hwang, Hyun Jeong Shim, Sang Hee Cho, Ki Hyeong Lee, Hye Suk Han, Eun-Kee Song, Hwan Jung Yun, In Sung Cho, Joon Kyoo Lee, Sang-Chul Lim, Woong-Ki Chung, Ik-Joo Chung

Published in: BMC Cancer | Issue 1/2013

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Abstract

Background

The purpose of this study was to evaluate the efficacy and tolerability of weekly docetaxel, cisplatin, and S-1 (weekly TPS) as induction chemotherapy for patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

Methods

A total of 35 patients with previously untreated, locally advanced HNSCC were enrolled. Seven patients (20%) were diagnosed with stage III HNSCC and 28 patients (80%) were diagnosed with stage IV. Induction treatment included 30 mg/m2 docetaxel on day 1 and 8, 60 mg/m2 cisplatin on day 1, and 70 mg/m2 S-1 on days 1 to 14. The regimen was repeated every 21 days. After three courses of induction chemotherapy, patients received concurrent chemoradiotherapy.

Results

Among the 35 patients, 30 (85.7%) completed induction chemotherapy. The response to induction chemotherapy was as follows: nine patients (25.7%) achieved a complete response (CR) and the overall response rate (ORR) was 85.7%. Grades 3–4 toxicity during induction therapy included neutropenia (28.5%), neutropenic fever (8.5%), and diarrhea (17.1%). After completion of concurrent chemoradiotherapy, the CR rate was 62.8% and the partial response (PR) was 22.8%. Estimates of progression-free and overall survival at 2 years were 73.2% and 79.3%, respectively.

Conclusions

Weekly TPS is a promising regimen that is well-tolerated, causes minimal myelosuppression and is effective as an outpatient regimen for locally advanced HNSCC.

Trial registration

ClinicalTrials.gov: NCT01645748
Appendix
Available only for authorised users
Literature
1.
Jemal A, Murray T, Ward E, Samuels A, Tiwari RC, Ghafoor A, Feuer EJ, Thun MJ: Cancer statistics, 2005. CA Cancer J Clin. 2005, 55 (1): 10-30. 10.3322/canjclin.55.1.10.CrossRefPubMed
2.
Vokes EE, Weichselbaum RR, Lippman SM, Hong WK: Head and neck cancer. N Engl J Med. 1993, 328 (3): 184-194. 10.1056/NEJM199301213280306.CrossRefPubMed
3.
Munro AJ: An overview of randomised controlled trials of adjuvant chemotherapy in head and neck cancer. Br J Cancer. 1995, 71 (1): 83-91. 10.1038/bjc.1995.17.CrossRefPubMedPubMedCentral
4.
El-Sayed S, Nelson N: Adjuvant and adjunctive chemotherapy in the management of squamous cell carcinoma of the head and neck region. A meta-analysis of prospective and randomized trials. J Clin Oncol. 1996, 14 (3): 838-847.PubMed
5.
Rinehart J, Ruff T, Cheung A, Hutchinson L, Tuggle R, Pinkston DR, Keville L, Wong L: Neoadjuvant and concomitant chemotherapy and radiation therapy in patients with advanced head and neck carcinoma. Otolaryngol Head Neck Surg. 2005, 132 (1): 69-74. 10.1016/j.otohns.2004.08.006.CrossRefPubMed
6.
Paccagnella A, Orlando A, Marchiori C, Zorat PL, Cavaniglia G, Sileni VC, Jirillo A, Tomio L, Fila G, Fede A, et al: Phase III trial of initial chemotherapy in stage III or IV head and neck cancers: a study by the Gruppo di Studio sui Tumori della Testa e del Collo. J Natl Cancer Inst. 1994, 86 (4): 265-272. 10.1093/jnci/86.4.265.CrossRefPubMed
7.
Lefebvre JL, Chevalier D, Luboinski B, Kirkpatrick A, Collette L, Sahmoud T: Larynx preservation in pyriform sinus cancer: preliminary results of a European Organization for Research and Treatment of Cancer phase III trial. EORTC Head and Neck Cancer Cooperative Group. J Natl Cancer Inst. 1996, 88 (13): 890-899. 10.1093/jnci/88.13.890.CrossRefPubMed
8.
Guadagnolo BA, Haddad RI, Posner MR, Weeks L, Wirth LJ, Norris CM, Sullivan CA, Goguen L, Busse PM, Tishler R: Organ preservation and treatment toxicity with induction chemotherapy followed by radiation therapy or chemoradiation for advanced laryngeal cancer. Am J Clin Oncol. 2005, 28 (4): 371-378. 10.1097/01.coc.0000162423.13431.8d.CrossRefPubMed
9.
Adelstein DJ, Saxton JP, Lavertu P, Rybicki LA, Esclamado RM, Wood BG, Strome M, Carroll MA: Maximizing local control and organ preservation in stage IV squamous cell head and neck cancer With hyperfractionated radiation and concurrent chemotherapy. J Clin Oncol. 2002, 20 (5): 1405-1410. 10.1200/JCO.20.5.1405.CrossRefPubMed
10.
Denis F, Garaud P, Bardet E, Alfonsi M, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Calais G: Final results of the 94–01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant radiochemotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004, 22 (1): 69-76.CrossRefPubMed
11.
Posner MR, Haddad RI, Wirth L, Norris CM, Goguen LA, Mahadevan A, Sullivan C, Tishler RB: Induction chemotherapy in locally advanced squamous cell cancer of the head and neck: evolution of the sequential treatment approach. Semin Oncol. 2004, 31 (6): 778-785. 10.1053/j.seminoncol.2004.09.007.CrossRefPubMed
12.
Jacobs C, Goffinet DR, Goffinet L, Kohler M, Fee WE: Chemotherapy as a substitute for surgery in the treatment advanced resectable head and neck cancer. A report from the Northern California Oncology Group. Cancer. 1987, 60 (6): 1178-1183. 10.1002/1097-0142(19870915)60:6<1178::AID-CNCR2820600604>3.0.CO;2-S.CrossRefPubMed
13.
Pignon JP, Bourhis J, Domenge C, Designe L: Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: three meta-analyses of updated individual data. MACH-NC Collaborative Group. Meta-Analysis of Chemotherapy on Head and Neck Cancer. Lancet. 2000, 355 (9208): 949-955.CrossRefPubMed
14.
Hitt R, Paz-Ares L, Brandariz A, Castellano D, Pena C, Millan JM, Calvo F, Ortiz De Urbina D, Lopez E, Alvarez-Vicent JJ, et al: Induction chemotherapy with paclitaxel, cisplatin and 5-fluorouracil for squamous cell carcinoma of the head and neck: long-term results of a phase II trial. Ann Oncol. 2002, 13 (10): 1665-1673. 10.1093/annonc/mdf268.CrossRefPubMed
15.
Posner MR, Glisson B, Frenette G, Al-Sarraf M, Colevas AD, Norris CM, Seroskie JD, Shin DM, Olivares R, Garay CA: Multicenter phase I-II trial of docetaxel, cisplatin, and fluorouracil induction chemotherapy for patients with locally advanced squamous cell cancer of the head and neck. J Clin Oncol. 2001, 19 (4): 1096-1104.PubMed
16.
Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, et al: Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007, 357 (17): 1695-1704. 10.1056/NEJMoa071028.CrossRefPubMed
17.
Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, et al: Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007, 357 (17): 1705-1715. 10.1056/NEJMoa070956.CrossRefPubMed
18.
Ahn JS, Cho SH, Kim OK, Lee JK, Yang DH, Kim YK, Lee JJ, Lim SC, Kim HJ, Chung WK, et al: The efficacy of an induction chemotherapy combination with docetaxel, cisplatin, and 5-FU followed by concurrent chemoradiotherapy in advanced head and neck cancer. Cancer Res Treat. 2007, 39 (3): 93-98. 10.4143/crt.2007.39.3.93.CrossRefPubMedPubMedCentral
19.
Gervais R, Ducolone A, Breton JL, Braun D, Lebeau B, Vaylet F, Debieuvre D, Pujol JL, Tredaniel J, Clouet P, et al: Phase II randomised trial comparing docetaxel given every 3 weeks with weekly schedule as second-line therapy in patients with advanced non-small-cell lung cancer (NSCLC). Ann Oncol. 2005, 16 (1): 90-96. 10.1093/annonc/mdi018.CrossRefPubMed
20.
Camps C, Massuti B, Jimenez A, Maestu I, Gomez RG, Isla D, Gonzalez JL, Almenar D, Blasco A, Rosell R, et al: Randomized phase III study of 3-weekly versus weekly docetaxel in pretreated advanced non-small-cell lung cancer: a Spanish Lung Cancer Group trial. Ann Oncol. 2006, 17 (3): 467-472. 10.1093/annonc/mdj115.CrossRefPubMed
21.
Schuette W, Nagel S, Blankenburg T, Lautenschlaeger C, Hans K, Schmidt EW, Dittrich I, Schweisfurth H, von Weikersthal LF, Raghavachar A, et al: Phase III study of second-line chemotherapy for advanced non-small-cell lung cancer with weekly compared with 3-weekly docetaxel. J Clin Oncol. 2005, 23 (33): 8389-8395. 10.1200/JCO.2005.02.3739.CrossRefPubMed
22.
Shirasaka T, Shimamato Y, Ohshimo H, Yamaguchi M, Kato T, Yonekura K, Fukushima M: Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anticancer Drugs. 1996, 7 (5): 548-557. 10.1097/00001813-199607000-00010.CrossRefPubMed
23.
Rapidis AD, Trichas M, Stavrinidis E, Roupakia A, Ioannidou G, Kritselis G, Liossi P, Giannakouras G, Douzinas EE, Katsilieris I: Induction chemotherapy followed by concurrent chemoradiation in advanced squamous cell carcinoma of the head and neck: final results from a phase II study with docetaxel, cisplatin and 5-fluorouracil with a four-year follow-up. Oral Oncol. 2006, 42 (7): 675-684. 10.1016/j.oraloncology.2005.12.006.CrossRefPubMed
24.
Lorenzen S, Hentrich M, Haberl C, Heinemann V, Schuster T, Seroneit T, Roethling N, Peschel C, Lordick F: Split-dose docetaxel, cisplatin and leucovorin/fluorouracil as first-line therapy in advanced gastric cancer and adenocarcinoma of the gastroesophageal junction: results of a phase II trial. Ann Oncol. 2007, 18 (10): 1673-1679. 10.1093/annonc/mdm269.CrossRefPubMed
25.
Chun JH, Kim HK, Lee JS, Choi JY, Hwangbo B, Lee HG, Park SR, Choi IJ, Kim CG, Ryu KW, et al: Weekly docetaxel in combination with capecitabine in patients with metastatic gastric cancer. Am J Clin Oncol. 2005, 28 (2): 188-194. 10.1097/01.coc.0000143877.53314.9c.CrossRefPubMed
26.
Burstein HJ, Manola J, Younger J, Parker LM, Bunnell CA, Scheib R, Matulonis UA, Garber JE, Clarke KD, Shulman LN, et al: Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol. 2000, 18 (6): 1212-1219.PubMed
27.
Kushner DM, Connor JP, Sanchez F, Volk M, Schink JC, Bailey HH, Harris LS, Stewart SL, Fine J, Hartenbach EM: Weekly docetaxel and carboplatin for recurrent ovarian and peritoneal cancer: a phase II trial. Gynecol Oncol. 2007, 105 (2): 358-364. 10.1016/j.ygyno.2006.12.018.CrossRefPubMed
28.
Bria E, Cuppone F, Ciccarese M, Nistico C, Facciolo F, Milella M, Izzo F, Terzoli E, Cognetti F, Giannarelli D: Weekly docetaxel as second line chemotherapy for advanced non-small-cell lung cancer: meta-analysis of randomized trials. Cancer Treat Rev. 2006, 32 (8): 583-587. 10.1016/j.ctrv.2006.07.003.CrossRefPubMed
29.
Inuyama Y, Kida A, Tsukuda M, Kohno N, Satake B: Early phase II study of S-1 in patients with advanced head and neck cancer. S-1 Cooperative Study Group (Head and Neck Working Group). Gan To Kagaku Ryoho. 1998, 25 (8): 1151-1158.PubMed
30.
Inuyama Y, Kida A, Tsukuda M, Kohno N, Satake B: Late phase II study of S-1 in patients with advanced head and neck cancer. Gan To Kagaku Ryoho. 2001, 28 (10): 1381-1390.PubMed
31.
Fujii M, Tomita K, Nishijima W, Tsukuda M, Hasegawa Y, Ishitoya J, Yamane H, Homma A, Tomita T: Phase I/II study of s-1 plus cisplatin combination chemotherapy in patients with advanced/recurrent head and neck cancer. Jpn J Clin Oncol. 2010, 40 (3): 214-221. 10.1093/jjco/hyp153.CrossRefPubMed
32.
Choi YJ, Chung JS, Shin HJ, Cho GJ, Wang SG, Lee BJ, Cho BM, Joo YD, Sohn CH: Induction chemotherapy with S-1 plus cisplatin in patients with locally advanced squamous cell carcinoma of the head and neck. J Laryngol Otol. 2008, 122 (8): 848-853.CrossRefPubMed
33.
Nakayama N, Koizumi W, Sasaki T, Higuchi K, Tanabe S, Nishimura K, Katada C, Nakatani K, Takagi S, Saigenji K: A multicenter, phase I dose-escalating study of docetaxel, cisplatin and S-1 for advanced gastric cancer (KDOG0601). Oncology. 2008, 75 (1–2): 1-7.CrossRefPubMed
34.
Takayama T, Sato Y, Sagawa T, Okamoto T, Nagashima H, Takahashi Y, Ohnuma H, Kuroiwa G, Miyanishi K, Takimoto R, et al: Phase I study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer. Br J Cancer. 2007, 97 (7): 851-856.PubMedPubMedCentral
35.
Fushida S, Fujimura T, Oyama K, Yagi Y, Kinoshita J, Ohta T: Feasibility and efficacy of preoperative chemotherapy with docetaxel, cisplatin and S-1 in gastric cancer patients with para-aortic lymph node metastases. Anticancer Drugs. 2009, 20 (8): 752-756. 10.1097/CAD.0b013e32832ec02b.CrossRefPubMed
36.
Wirth LJ, Posner MR: Recent advances in combined modality therapy for locally advanced head and neck cancer. Curr Cancer Drug Targets. 2007, 7 (7): 674-680. 10.2174/156800907782418329.CrossRefPubMed
37.
Tahara M, Araki K, Okano S, Kiyota N, Fuse N, Minashi K, Yoshino T, Doi T, Zenda S, Kawashima M, et al: Phase I trial of combination chemotherapy with docetaxel, cisplatin and S-1 (TPS) in patients with locally advanced or recurrent/metastatic head and neck cancer. Ann Oncol. 2011, 22 (1): 175-180. 10.1093/annonc/mdq298.CrossRefPubMed
38.
Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, et al: Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004, 350 (19): 1937-1944. 10.1056/NEJMoa032646.CrossRefPubMed
Metadata
Title
Multicenter phase II study of weekly docetaxel, cisplatin, and S-1 (TPS) induction chemotherapy for locally advanced squamous cell cancer of the head and neck
Authors
Woo Kyun Bae
Jun Eul Hwang
Hyun Jeong Shim
Sang Hee Cho
Ki Hyeong Lee
Hye Suk Han
Eun-Kee Song
Hwan Jung Yun
In Sung Cho
Joon Kyoo Lee
Sang-Chul Lim
Woong-Ki Chung
Ik-Joo Chung
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2013
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-13-102

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