Ettinger D S, Finkelstein D M, Abeloff M D, Ruckdeschel J C, Aisner S C, Eggleston J C
Johns Hopkins Oncology Center, Baltimore, MD 21205.
J Clin Oncol. 1990 Feb;8(2):230-40. doi: 10.1200/JCO.1990.8.2.230.
The present randomized, prospective study was designed to assess whether alternating induction cyclophosphamide, doxorubicin, vincristine-altretamine (hexamethylmelamine), etoposide, and methotrexate (CAV-HEM) chemotherapy is better than standard chemotherapy (CAV) in improving response, survival, and remission time in 577 evaluable patients having extensive-disease small-cell lung cancer (SCLC). In addition, the study was designed to assess the impact of maintenance chemotherapy following a complete response (CR) on the time to progression and survival. The response rates (CR plus partial response [PR]) for CAV-HEM and CAV were 64% and 61%, respectively, but 23% of the patients on CAV-HEM achieved a CR compared with 16% for CAV alone (P = .03). Among complete responders, the continuation of therapy significantly increased the remission time for patients on CAV, while maintenance therapy for patients on CAV-HEM had no significant impact on remission time. However, the increased remission had little effect on survival. Patients on CAV maintenance therapy survived marginally longer than those patients on no maintenance therapy, whereas patients who received CAV-HEM and no maintenance therapy survived longer than those on maintenance therapy. CAV-HEM was associated with significantly higher severity of complications (ie, mainly myelosuppression) than CAV (P = .01). Maintenance chemotherapy was associated with significantly more complications than no maintenance therapy. Patients on CAV-HEM lived significantly longer than those on CAV alone (45.9 weeks v 42.7 weeks; P = .002). Ten percent of patients treated on CAV-HEM survived at least 2 years, compared with 4% on CAV alone. In our study involving patients with extensive-disease SCLC, the alternating induction chemotherapy significantly increased the CR rates and had a small impact on long-term survival compared with the results achieved with standard induction chemotherapy. Moreover, when the alternating induction chemotherapy was used, long-term maintenance chemotherapy was not needed.
本项随机前瞻性研究旨在评估交替使用环磷酰胺、阿霉素、长春新碱-六甲蜜胺、依托泊苷和甲氨蝶呤（CAV-HEM）进行化疗，在改善577例广泛期小细胞肺癌（SCLC）可评估患者的缓解率、生存率和缓解时间方面是否优于标准化疗（CAV）。此外，该研究旨在评估完全缓解（CR）后进行维持化疗对疾病进展时间和生存率的影响。CAV-HEM和CAV的缓解率（CR加部分缓解[PR]）分别为64%和61%，但接受CAV-HEM治疗的患者中有23%达到CR，而单独使用CAV的患者这一比例为16%（P = 0.03）。在完全缓解者中，继续治疗显著延长了接受CAV治疗患者的缓解时间，而对接受CAV-HEM治疗的患者进行维持治疗对缓解时间无显著影响。然而，缓解时间的延长对生存率影响不大。接受CAV维持治疗的患者比未接受维持治疗的患者生存时间略长，而接受CAV-HEM且未接受维持治疗的患者比接受维持治疗的患者生存时间更长。与CAV相比，CAV-HEM的并发症严重程度显著更高（即主要是骨髓抑制，P = 0.01）。维持化疗比不进行维持化疗的并发症显著更多。接受CAV-HEM治疗的患者比单独接受CAV治疗的患者生存时间显著更长（45.9周对42.7周；P = 0.002）。接受CAV-HEM治疗的患者中有10%至少存活了2年，而单独接受CAV治疗的患者这一比例为4%。在我们这项涉及广泛期SCLC患者的研究中，与标准化疗相比，交替诱导化疗显著提高了CR率，对长期生存有轻微影响。此外，使用交替诱导化疗时，无需进行长期维持化疗。
