title: [Assessment of a phase III trial of adjuvant chemotherapy in resected lung cancer: an imbalance of surgical results among cooperative institutions].
abstract: Many investigators have studied the benefit of adjuvant chemotherapy (AC) in resected lung cancer. However, its benefit is still controversial, except for small cell lung cancer. In the present study, we discussed problems in the preparation of a phase III trial of AC in resected lung cancer. Since a phase III trial requires generally large sample sizes for a short period, a multicenter approach is frequently necessary. However, there are several problems in the preparation of such trial. Firstly, we found that survival for resected lung cancer was considerably different among institutions. Overall 5-year survival for 279 resected N2 disease collected from 7 major institutions was 23%. The 5-year survival for each institution, however, ranged from 7 to 41%. This difference is probably caused by the fact that surgical indication, an ability in operation and postoperative care are different among institutions. Secondly, the number of patients enrolled in the trial spread widely among cooperative institutions. In a phase III trial of AC for resected stage III A patients, 209 patients were collected from 25 institutions. The number of patients enrolled from individual institutions ranged from 0 to 25. Only 5 institutions were possible to enter more than 10 evaluable patients on the trial. Recently, a phase III trial of neoadjuvant therapy was carried out in stage III A (T1-2N2) patients at 5 major institutions. Patients were treated initially with 2 cycles of chemotherapy (CDDP + VDS + MMC), followed by surgical resection. Of 22 resected patients, 4 who underwent extended pneumonectomy, happened to die postoperatively only in one institution. This also shows an imbalance of surgical results among cooperative institutions. In conclusion, we consider that it is particularly important to select institutions without an imbalance of surgical results in a phase III trial.
authors.affiliation: Dept. of Chest Surgery, National Kyushu Cancer Center.
authors.forename: M
authors.initials: M
authors.lastname: Ohta
authors.forename: N
authors.initials: N
authors.lastname: Hara
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage; D002986:Clinical Trials as Topic / Q000592:standards; D003131:Combined Modality Therapy; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D016685:Mitomycin; D008937:Mitomycins / Q000008:administration & dosage; D015337:Multicenter Studies as Topic / Q000379:methods / Q000592:standards*; D015996:Survival Rate; D014751:Vindesine / Q000008:administration & dosage
chemical_list: D008937:Mitomycins; D016685:Mitomycin; D002945:Cisplatin; D014751:Vindesine