Souquet P J, Fournel P, Bohas C H, Fortune I C, Chatte G
Department of Pneumology and Thoracic Oncology, Centre Hospitalier Lyon Sud, Pierre Benite, France.
Semin Oncol. 1996 Apr;23(2 Suppl 5):8-10.
From November 1992 to March 1994 we concluded a phase II trial of the combination of cisplatin 75 mg/m2 and ifosfamide 3 g/m2 on day 1 and increasing doses of vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France). Group A was given vinorelbine 25 mg/m2 on day 1, group B 25 mg/m2 on days 1 and 8, and group C 25 mg/m2 on days 1 and 15 and 12.5 mg/m2 on day 8. Inclusion criteria were histologically proven non-small cell lung cancer, stage IIIB or IV disease, no underlying disease, performance status < 2, no previous chemotherapy or radiotherapy, not older than 75 years, and informed consent. Treatment was given for 3 weeks. Eighty-six patients were included: 34 in group A, 28 in group B, and 24 in group C. One patient in group B was excluded because of false histology on review. Thirty-seven patients had stage IIIB and 48 had state IV disease, and 37 had squamous cell carcinoma, 32 had adenocarcinoma, and 16 had large cell carcinoma. The median age was 59.2 years (age range, 36 to 73 years). Evaluation was made 3 weeks after the third course of therapy. Thoracic radiotherapy (60 Gy) was given in stage IIIB disease; in stage IV disease, when an objective response was achieved, three additional courses of chemotherapy were given. The response rate after three cycles was 32% in group A, 44% in group B, and 67% in group C. Dose intensity, using Hryniuk's method, was the same for cisplatin and ifosfamide in the three groups. Dose intensity for vinorelbine was 8.1 mg/m2/wk in group A, 14.7 mg/m2/wk in group B, and 16.9 mg/m2/wk in group C. This study shows that increased dose intensity with vinorelbine is feasible and seems to increase the response rate and median survival, which was 28 weeks in group A and 38 weeks in group B. Median survival had not been reached in group C.
1992年11月至1994年3月，我们开展了一项II期试验，采用顺铂75mg/m²和异环磷酰胺3g/m²于第1天联合使用，并递增剂量的长春瑞滨（诺维本；百时美施贵宝公司，北卡罗来纳州三角研究园；法国巴黎皮尔法伯制药公司）。A组于第1天给予长春瑞滨25mg/m²，B组于第1天和第8天给予25mg/m²，C组于第1天和第15天给予25mg/m²，第8天给予12.5mg/m²。纳入标准为经组织学证实的非小细胞肺癌、IIIB期或IV期疾病、无基础疾病、体能状态＜2、既往未接受过化疗或放疗、年龄不超过75岁且签署知情同意书。治疗为期3周。共纳入86例患者：A组34例，B组28例，C组24例。B组有1例患者因复查时组织学结果有误而被排除。37例患者为IIIB期，48例为IV期疾病，37例为鳞状细胞癌，32例为腺癌，16例为大细胞癌。中位年龄为59.2岁（年龄范围36至73岁）。在第三个疗程治疗3周后进行评估。IIIB期疾病给予胸部放疗（60Gy）；IV期疾病若获得客观缓解，则再给予三个疗程的化疗。三个周期后的缓解率A组为32%，B组为44%，C组为67%。采用赫里纽克方法计算，三组中顺铂和异环磷酰胺的剂量强度相同。A组长春瑞滨的剂量强度为8.1mg/m²/周，B组为14.7mg/m²/周，C组为16.9mg/m²/周。本研究表明，增加长春瑞滨的剂量强度是可行的，似乎能提高缓解率和中位生存期，A组中位生存期为28周，B组为38周。C组中位生存期尚未达到。
