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非小細胞肺癌新規抗癌剤第II相試験における評価基準としての奏効率の検討：関根郁夫¹, 久保田馨¹,西脇裕²,佐々木康綱³,田村友秀¹,西條長宏¹（¹国立がんセ,中央,内,²同東,呼吸器,³同東,化学療法）

Response rate as an endpoint of new agent phase II trials for non-small cell lung cancer: Ikuo SEKINE¹, Kaoru KUBOTA¹, Yutaka NISHIWAKI², Yasutsuna SASAKI³, Tomohide TAMURA¹, Nagahiro SAIJO¹ (¹Div. of Int. Med., Natl. Cancer Ctr. Hosp., ²Thoracic Oncol. and ³Oncol./Hematol. Divs, Natl. Cancer Ctr. Hosp. East)

Background: Response rate (RR) has been used as a definitive endpoint of phase II trials for new agents in non-small cell lung cancer (NSCLC). However, tumor responses to chemotherapy do not always result in prolonged survival of patients with this disease. Design: Single-agent phase II trials were identified by a MEDLINE search during the period from 1976 to 1995. Associations between RR, median survival time (MST) and characteristics of patients who entered the trial, including tumor extent, performance status and prior chemotherapy, were studied by using the logistic regression model. Results: A total of 183 treatment arms in 176 trials were identified. The overall RR in the 6768 evaluable patients was 11%. Eleven drugs, cisplatin, epirubicin, ifosfamide, edatrexate, irinotecan, vinorelbine, docetaxel, paclitaxel, etoposide, vindesine, and 254-S produced a RR of more than 20%. An MST of 8 months or longer was obtained with 12 drugs. Three of them, however, produced no objective responses at least in one trial. MST was significantly correlated with RR (r = 0.504, p < 0.0001), but ranged broadly at a given level of RR. Multivariate analysis yielded a dose-dependent association between RR and MST after adjustment for other variables. Conclusion: RR was significantly correlated with MST in single-agent phase II trials for NSCLC, but there is still room for further consideration of the endpoint of these trials.