Phase II Study of S-1 Plus Either Irinotecan or Docetaxel for Non-small Cell Lung Cancer Patients Treated with More Than Three Lines of Treatment
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Purpose This study was designed to evaluate the efficacy of a combination treatment of S-1 plus either irinotecan or docetaxel for advanced/metastatic non-small cell lung cancer (NSCLC) patients who have already failed 3 or more lines of treatment. Materials and Methods This was a prospective single center phase II study. The eligible patients received S-1 40 mg/m2twice a day orally on days 1 though 14 combined with irinotecan 150 mg/m2on D1 only or docetaxel 35 mg/m2 on D1 and D8. The treatment was repeated every 3 weeks until disease progression,unacceptable toxicity, or patient refusal. The choice between the two regimens was made at the discretion of the treating physician. Results A total of 14 patients participated in the study. There were 3 patients with squamous cell carcinoma,9 with adenocarcinoma, and 2 with NSCLC, NOS. Eight of the patients were male. There were 8 patients with an Eastern Cooperative Oncology Group (ECOG) of 1, and 6 patients with an ECOG of 2. All the patients had already been treated with platinum-based chemotherapy and epidermal growth factor receptor tyrosine kinase inhibitor therapy. Out of the 14 patients, 10 received irinotecan and S-1 and the other 4 received docetaxel and S-1. Twelve patients had also received pemetrexed. Disappointingly, there were no response from 2 patients with a stable disease, and therefore, as per the protocol, we stopped the study early. With a median follow-up time of 49months, the median survival time was 5.6 months (95% confidence interval, 4.3 to 6.9 months). Conclusion S-1 containing doublets did not show activity in this population as a salvage treatment and further investigation cannot be recommended.
Abstract
Purpose This study was designed to evaluate the efficacy of a combination treatment of S-1 plus either irinotecan or docetaxel for advanced/metastatic non-small cell lung cancer (NSCLC) patients who have already failed 3 or more lines of treatment. Materials and Methods This was a prospective single center phase II study. The eligible patients received S-1 40 mg/m2twice a day orally on days 1 though 14 combined with irinotecan 150 mg/m2on D1 only or docetaxel 35 mg/m2 on D1 and D8. The treatment was repeated every 3 weeks until disease progression,unacceptable toxicity, or patient refusal. The choice between the two regimens was made at the discretion of the treating physician. Results A total of 14 patients participated in the study. There were 3 patients with squamous cell carcinoma,9 with adenocarcinoma, and 2 with NSCLC, NOS. Eight of the patients were male. There were 8 patients with an Eastern Cooperative Oncology Group (ECOG) of 1, and 6 patients with an ECOG of 2. All the patients had already been treated with platinum-based chemotherapy and epidermal growth factor receptor tyrosine kinase inhibitor therapy. Out of the 14 patients, 10 received irinotecan and S-1 and the other 4 received docetaxel and S-1. Twelve patients had also received pemetrexed. Disappointingly, there were no response from 2 patients with a stable disease, and therefore, as per the protocol, we stopped the study early. With a median follow-up time of 49months, the median survival time was 5.6 months (95% confidence interval, 4.3 to 6.9 months). Conclusion S-1 containing doublets did not show activity in this population as a salvage treatment and further investigation cannot be recommended.
참고문헌 (21)
- Schiller JH, "Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer", N Engl J Med, 346, pp.92~98 (2002)
- 노재경, "Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial", Lancet, 373(9674), pp.1525~1531
- Sandler A, "Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer", N Engl J Med, 355, pp.2542~2550 (2006)
- Shepherd FA, "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, pp.2095~2103 (2000)
- Hanna N, "Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy", J Clin Oncol, 22, pp.1589~1597 (2004)
- Shepherd FA, "Erlotinib in previously treated non-small-cell lung cancer", N Engl J Med, 353, pp.123~132 (2005)
- Kim ES, "Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial", Lancet, 372, pp.1809~1818 (2008)
- Shirasaka T, "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, 7, pp.548~557 (1996)
- Shirasaka T, "Inhibition by oxonic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats", Cancer Res, 53, pp.4004~4009 (1993)
- Okamoto I, "Phase III trial comparing oral S-1 plus carboplatin with paclitaxel plus carboplatin in chemotherapy-naïve patients with advanced non-small-cell lung cancer: results of a west Japan oncology group study", J Clin Oncol, 28, pp.5240~5246 (2010)
- Govindan R, "Phase II trial of S-1 as second-line therapy in patients with advanced non-small cell lung cancer", J Thorac Oncol, 6, pp.790~795 (2011)
- Ono A, "Evaluation of S-1 as third- or further-line chemotherapy in advanced non-small-cell lung cancer", Int J Clin Oncol, 15, pp.161~165 (2010)
- Han JY, "A phase II study of weekly docetaxel plus capecitabine for patients with advanced nonsmall cell lung carcinoma", Cancer, 98, pp.1918~1924 (2003)
- Han JY, "A Phase II study of weekly irinotecan and capecitabine in patients with previously treated non-small cell lung cancer", Clin Cancer Res, 9(16), pp.5909~5914 (2003)
- Han JY, "Phase II study of weekly irinotecan plus capecitabine for chemotherapy-naïve patients with advanced nonsmall cell lung carcinoma", Cancer, 104, pp.2759~2765 (2005)
- Lee JJ, "A phase II trial of docetaxel plus capecitabine in patients with previously treated non-small cell lung cancer", Jpn J Clin Oncol, 36, pp.761~767 (2006)
- Chen YM, "Third-line or fourth-line chemotherapy in non-small-cell lung cancer patients with relatively good performance status", J Chin Med Assoc, 74, pp.209~214 (2011)
- Fox E, "Clinical trial design for target-based therapy", Oncologist, 7, pp.401~409 (2002)
- Adjei AA, "Correlation between polymorphisms of the reduced folate carrier gene (SLC19A1) and survival after pemetrexed- based therapy in non-small cell lung cancer: a North Central Cancer Treatment Group-based exploratory study", J Thorac Oncol, 5, pp.1346~1353 (2010)
- Kim ES, "The BATTLE tiral: personalizing therapy for lung cancer", Cancer Discov, 1, pp.44~53 (2011)
- Kris MG, "Identification of driver mutations in tumor specimens from 1,000 patients with lung adenocarcinoma: The NCI’s Lung Cancer Mutation Consortium (LCMC)", J Clin Oncol, 29(s), pp.CRA7506~ (2011)