Loehrer P J, Chen M, Kim K, Aisner S C, Einhorn L H, Livingston R, Johnson D
Department of Medicine, Indiana University Medical Center, Indianapolis 46202-5265, USA.
J Clin Oncol. 1997 Sep;15(9):3093-9. doi: 10.1200/JCO.1997.15.9.3093.
To determine the response rate of cisplatin plus doxorubicin plus cyclophosphamide (PAC) in patients with limited-stage unresectable thymoma. In addition, this study was undertaken to determine the toxicity, progression-free survival, and overall survival of combined-modality therapy with PAC plus radiation therapy.
Patients with a histologic diagnosis of limited-stage unresectable thymoma or thymic carcinoma were eligible. Further requirements included a Karnofsky Performance Score of > 60, no prior radiation to the chest, and adequate bone marrow, hepatic, and renal function. No patient had undergone chemotherapy previously. Patients received two to four cycles (repeated every 3 weeks) of cisplatin (50 mg/m2), doxorubicin (50 mg/m2), and cyclophosphamide (500 mg/m2) followed by a total dosage of 54 Gy to the primary tumor and regional lymph nodes for patients with a stable, partial, or complete response to chemotherapy.
From November 1983 through January 1995, 26 patients were entered onto the trial. Three patients were ineligible on the basis of pathologic review (lung cancer, germ cell cancer, lymphoma). Toxicity, primarily hematologic, was mild, with only one early death due to a perforated abdominal viscus. Among the 23 assessable patients, there were five complete and 11 partial responses to chemotherapy (overall response rate, 69.6%). The median time to treatment failure was 93.2 months (range, 3 to 99.2+ months), and the median survival time was 93 months (range, 1 to 110 months). The 5-year survival rate is 52.5%.
PAC combination chemotherapy produces response rates in the management of patients with limited thymoma. Combined-modality therapy is feasible and associated with prolonged progressive-free survival. The benefit of combined-modality therapy over radiation therapy alone is suggested for patients with unresectable thymoma.
确定顺铂加阿霉素加环磷酰胺(PAC)方案对局限期不可切除胸腺瘤患者的缓解率。此外,本研究旨在确定PAC联合放射治疗的毒性、无进展生存期和总生存期。
组织学诊断为局限期不可切除胸腺瘤或胸腺癌的患者符合条件。进一步要求包括卡氏功能状态评分>60、胸部未接受过放疗、骨髓、肝脏和肾功能正常。此前无患者接受过化疗。患者接受两至四个周期(每3周重复一次)的顺铂(50mg/m²)、阿霉素(50mg/m²)和环磷酰胺(500mg/m²)治疗,对于化疗后病情稳定、部分缓解或完全缓解的患者,对原发肿瘤和区域淋巴结给予总剂量54Gy的放疗。
从1983年11月至1995年1月,26例患者进入试验。经病理复查,3例患者不符合条件(肺癌、生殖细胞癌、淋巴瘤)。毒性主要为血液学毒性,程度较轻,仅1例因腹腔脏器穿孔早期死亡。在23例可评估患者中,化疗后有5例完全缓解和11例部分缓解(总缓解率为69.6%)。治疗失败的中位时间为93.2个月(范围为3至99.2+个月),中位生存时间为93个月(范围为1至110个月)。5年生存率为52.5%。
PAC联合化疗对局限期胸腺瘤患者的治疗有缓解率。联合治疗可行且与延长的无进展生存期相关。对于不可切除胸腺瘤患者,联合治疗可能比单纯放疗更有益。