Elias L, Blumenstein B A, Kish J, Flanigan R C, Wade J L, Lowe B A, Goodwin J W, Crawford E D
Cancer Research and Treatment Center, University of New Mexico, Albuquerque, New Mexico.
Cancer. 1996 Sep 1;78(5):1085-8. doi: 10.1002/(SICI)1097-0142(19960901)78:5<1085::AID-CNCR19>3.0.CO;2-Z.
Renal cell carcinoma is a common neoplasm that is often refractory to treatment. It is occasionally responsive to immunomodulating agents including interferon-alpha, which enhances the effects of 5-fluorouracil upon cells. Combinations of these two drugs have been most frequently tested in patients with gastrointestinal cancers, with some promising results. Because interferon-alpha has activity for renal cell carcinoma, a trial of this combination in patients with this malignancy was undertaken.
The Southwest Oncology Group performed a Phase II clinical trial of the combination of 5-fluorouracil and interferon-alpha for recurrent or metastatic renal cell carcinoma. Eligibility criteria included no prior treatment with medications for cancer, a performance status of 2 or better, and bidimensionally measurable disease. The regimen studied consisted of 5-fluorouracil, 750 mg/M2/day, by continuous intravenous infusion on Days 1-5, and interferon-alpha-2b (Intron A), 5 x 10(6)U/M2/day, subcutaneously on Days 1, 3, and 5, repeated every 21 days.
Forty eligible patients were treated; twenty of the 40 underwent a nephrectomy. The regimen was tolerable: 3 patients had Grade 4, and 17 had Grade 3 toxicity. There were 5 partial responses (13% with 95% confidence limits of 4-27%). Median progression free survival for all 40 patients was 4 months and median overall survival was 15 months from the time of registration.
The combination of 5-fluorouracil and interferon-alpha given by this schedule, although tolerable and occasionally yielding responses, is not an improvement over existing therapies.
肾细胞癌是一种常见肿瘤，通常对治疗具有耐药性。它偶尔会对包括α-干扰素在内的免疫调节剂产生反应，α-干扰素可增强5-氟尿嘧啶对细胞的作用。这两种药物的联合应用在胃肠道癌患者中进行了最频繁的试验，取得了一些有前景的结果。由于α-干扰素对肾细胞癌有活性，因此对这种恶性肿瘤患者进行了该联合用药的试验。
西南肿瘤协作组对5-氟尿嘧啶与α-干扰素联合用于复发性或转移性肾细胞癌进行了一项II期临床试验。入选标准包括未曾接受过癌症药物治疗、体能状态为2级或更好以及具有可二维测量的疾病。所研究的方案包括在第1 - 5天通过持续静脉输注给予5-氟尿嘧啶，750 mg/M²/天，以及在第1、3和5天皮下给予α-干扰素-2b（Intron A），5×10⁶U/M²/天，每21天重复一次。
40名符合条件的患者接受了治疗；40名患者中有20名接受了肾切除术。该方案耐受性良好：3名患者出现4级毒性，17名患者出现3级毒性。40名患者的中位无进展生存期为4个月，从登记时起的中位总生存期为15个月。
按此方案给予5-氟尿嘧啶和α-干扰素的联合用药，尽管耐受性良好且偶尔产生反应，但并不比现有疗法有改善。
