Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-Ku, Yokohama, Kanagawa, 240-8555, Japan.
Cancer Chemother Pharmacol. 2012 Jun;69(6):1625-31. doi: 10.1007/s00280-012-1871-5. Epub 2012 May 8.
This study aimed to establish the maximum tolerated dose of concurrent chemoradiotherapy (cCRT) with conventional administration of the docetaxel (D) plus cisplatin (P) (conv-DP) regimen.
Patients (aged ≤70 years) with unresectable dry stage III non-small-cell lung cancer (NSCLC) and having performance status 0 or 1 and adequate organ function were eligible. They received radiotherapy (60 Gy in 30 fractions) once daily starting on day 2. Concurrent P (day 1; 60 mg/m(2) at Levels 1-3, 80 mg/m(2) at Level 4) and D (day 1; 30 mg/m(2) at Level 1, 40 mg/m(2) at Level 2, 50 mg/m(2) at Levels 3-4) were administered every 4 weeks for 2-4 courses.
Eighteen patients were enrolled (stage IIIA/IIIB, 5/13 patients). Three cases of dose-limiting toxicity were observed in this study, although another 3 cases were added at Levels 2 and 3. Radiotherapy was completed in 15 patients. Seventeen patients received more than 2 courses of chemotherapy. Neither Grade 3/4 esophagitis nor severe hematological events were observed at Levels 1-4. However, dose escalation to Level 5 (P [80 mg/m(2)], D [60 mg/m(2)]) was stopped because the Level 5 dose was the recommended dose (RD) of chemotherapy alone for stage IIIB/IV NSCLC in Japan. Therefore, the RD was determined as D50/P80 mg/m(2) in this cCRT. The objective response rate was 89%, and the median survival time was 23.6 months.
cCRT with non-split DP was a tolerable and effective regimen, and RD was 50/80 mg/m(2) every 4 weeks.
本研究旨在确定常规顺铂（P）加多西他赛（D）（conv-DP）方案同步放化疗（cCRT）的最大耐受剂量。
符合条件的患者为年龄≤70 岁的不可切除的干期 III 期非小细胞肺癌（NSCLC）患者，体力状态 0 或 1 级，且器官功能良好。他们在第 2 天开始接受每天 1 次的放疗（60 Gy，30 个分次）。在 4 周内，顺铂（第 1 天；1 级时 60 mg/m2，4 级时 80 mg/m2）和多西他赛（第 1 天；1 级时 30 mg/m2，2 级时 40 mg/m2，3-4 级时 50 mg/m2）以 2-4 个疗程给予同期治疗。
本研究共纳入 18 例患者（III 期/III 期，5/13 例）。尽管在 2 级和 3 级又增加了 3 例病例，但观察到 3 例剂量限制毒性。15 例患者完成了放疗。17 例患者接受了超过 2 个疗程的化疗。在 1-4 级未观察到 3/4 级食管炎或严重血液学事件。然而，由于日本 IIIB/IV 期 NSCLC 的推荐化疗剂量（RD）为 P（80 mg/m2），D（60 mg/m2），故停止了剂量升级至 5 级（P[80 mg/m2]，D[60 mg/m2]）。因此，本 cCRT 的 RD 确定为 D50/P80 mg/m2。客观缓解率为 89%，中位生存时间为 23.6 个月。
非分割 DP 的 cCRT 是一种耐受良好且有效的方案，RD 为每 4 周 50/80 mg/m2。
