Creagan E T, Ahmann D L, Green S J, Long H J, Rubin J, Schutt A J, Dziewanowski Z E
Cancer. 1984 Dec 15;54(12):2844-9. doi: 10.1002/1097-0142(19841215)54:12<2844::aid-cncr2820541205>3.0.co;2-q.
Thirty-one patients with disseminated malignant melanoma received intramuscular recombinant leukocyte A interferon (rIFN-alpha A), 50 X 10(6) units/m2 three times weekly for a planned treatment duration of 3 months. Seven objective regressions (23%), which ranged in duration from 3 to 11.2+ months, were observed. Forty-two percent of 12 patients who were fully active (Eastern Cooperative Oncology Group [ECOG] performance score, 0) responded compared to 11% of 19 patients with impairment of performance status (ECOG, 1-3). Prior chemotherapy did not influence response rate. For all patients the median time to progression and of survival was 2 months and 6 months, respectively. Four patients had partial regressions in soft tissue (3, 4.6 months), pulmonary (7 months), and prostatic lesions (3 months). The latter was biopsy-proven and assessed by serial computerized tomography (CT) scans. Three had complete regressions of soft tissue disease (2 patients, 6.4 and 10+ months each), and liver involvement (11.2+ months). The major toxicities were moderate to severe fatigue (87%), anorexia (58%), and confusion (23%). Performance score deteriorated in 84% of patients during the time they were receiving rIFN-alpha A. Among the 13 patients whose tumors did not progress for at least 12 weeks, 7 required dose reductions or termination of treatment due to toxicities. Hematologic and hepatic toxicity was transient and of little clinical significance. The study indicates that rIFN-alpha A has some antitumor activity accompanied by difficult side effects in patients with disseminated malignant melanoma.
31例播散性恶性黑色素瘤患者接受了肌肉注射重组白细胞A干扰素（rIFN-αA）治疗，剂量为50×10⁶单位/m²，每周3次，计划治疗持续3个月。观察到7例客观缓解（23%），缓解持续时间为3至11.2⁺个月。12例完全活动状态（东部肿瘤协作组[ECOG]体能状态评分，0）的患者中42%有反应，而19例体能状态受损（ECOG，1 - 3）的患者中只有11%有反应。既往化疗不影响反应率。所有患者的疾病进展中位时间和生存中位时间分别为2个月和6个月。4例患者的软组织（3例，4.6个月）、肺部（7个月）和前列腺病变（3个月）有部分缓解。后者经活检证实，并通过系列计算机断层扫描（CT）进行评估。3例患者的软组织疾病完全缓解（2例患者，分别为6.4个月和10⁺个月），肝脏受累完全缓解（11.2⁺个月）。主要毒性为中度至重度疲劳（87%）、厌食（58%）和意识模糊（23%）。84%的患者在接受rIFN-αA治疗期间体能状态评分恶化。在13例肿瘤至少12周未进展的患者中，7例因毒性反应需要减少剂量或终止治疗。血液学和肝脏毒性是短暂的，临床意义不大。该研究表明，rIFN-αA对播散性恶性黑色素瘤患者有一定抗肿瘤活性，但伴有难以处理的副作用。
