Phase II study of alpha interferon on renal cell carcinoma. Summary of three collaborative trials

Umeda, Takashi; Niijima, Tadao

doi:10.1002/1097-0142(19860915)58:6<1231::aid-cncr2820580610>3.0.co;2-#

Cited by 120 publications

(21 citation statements)

References 3 publications

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“…There have been a number of reports that cytokines, including IFN, are effective for controlling lung metastases in renal cell carcinoma. The response rate was reported to be 20.9% (34/163) for IFN-α, 15 18.0% (9/50) for IL-2, 6 and 23.8% (20/ 84) for a combination of IL-2 and IFN-α. 16 As the response rates in these reports were about 20%, the response rate of 38.7% observed in the present study was relatively high.…”

Section: Discussionmentioning

confidence: 99%

A low-dose combination therapy of interleukin-2 and interferon-α is effective for lung metastasis of renal cell carcinoma: a multicenter open study

et al. 2006

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Section: Discussionmentioning

confidence: 99%

A low-dose combination therapy of interleukin-2 and interferon-α is effective for lung metastasis of renal cell carcinoma: a multicenter open study

et al. 2006

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“…In phase II studies these drugs are associated both as single agent and in combination, with a response rate between 6 and 25% and a median survival of 8-14 months (Umeda and Niijima, 1986;Creagan et al, 1991;Gore et al, 1994;Fyfe et al, 1996). In a randomized phase III study the response rates of patients treated with IL-2, IFN-α or the combination were 6.5%, 7.5% and 18.6% respectively.…”

Section: Discussionmentioning

confidence: 99%

Immunochemotherapy with interleukin-2, interferon- α and 5-fluorouracil for progressive metastatic renal cell carcinoma: a multicenter phase II study

Herpen¹,

Jansen

Kruit

et al. 2000

Br J Cancer

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In patients with metastatic renal cell carcinoma response rates of 7–26% have been achieved with immunotherapy. A high response rate of 48% in 35 patients has been reported for treatment with the combination of interferon-α (IFN-α), interleukin-2 (IL-2) and 5-fluorouracil (5-FU) (Atzpodien et al (1993 a ) Eur J Cancer 29A : S6–8). We conducted a multicentre phase II study to confirm these results. Metastatic renal cell carcinoma patients were treated as outpatients with an 8-week treatment cycle. Recombinant human IL-2 20 MU m −2 was administered subcutaneously (s.c.) three times a week (t.i.w) in weeks 1 and 4 and 5 MU m −2 t.i.w. in weeks 2 and 3. Recombinant human IFN-α 2a 6 MU m −2 was administered s.c. once in weeks 1 and 4 and t.i.w. in weeks 2 and 3, and 9 MU m −2 t.i.w. in weeks 5–8. 5-FU (750 mg m −2 ) was given as a bolus injection intravenous once a week in weeks 5–8. The treatment cycle was repeated once in case of response or minor response. Fifty-two patients entered the study. All had undergone a nephrectomy and had progressive metastatic disease. The median WHO-performance status was 1, the median number of metastatic sites was 2 (range 1–5) and the median time between the diagnosis of the primary tumour and the start of treatment was 12.9 months (range 1–153). Among the 51 patients, including four patients with early progressive disease, who were evaluable for response, the response rate was 11.8% (95% confidence interval (CI) 2.9–20.7%), with no complete responses. Median duration of response was 8.3 (range 3.8–22.4+) months. Median survival was 16.5 (range 1.8–30.5+) months. Grade 3/4 toxicity (WHO) occurred in 29/52 (55.8%) of the patients in cycle 1 and in 6/16 (37.5%) of the patients in cycle 2. It consisted mainly of anorexia, fatigue, nausea, fever and leucocytopenia. We cannot confirm the high response rate in patients with metastatic renal cell carcinoma treated with the combination of IFN-α, IL-2 and 5-FU, as described by Atzpodien et al. © 2000 Cancer Research Campaign

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“…Multiple studies have shown that a modest percentage (12-20%) of good PS patients can experience PR or CR of mRCC with either agent [93,94]. Therefore, cytokines remain a treatment option for selected mRCC patients, both as a single treatment or as combination therapy.…”

Section: Chemoimmunotherapymentioning

confidence: 99%

Chemotherapy in metastatic renal cell carcinoma today? A systematic review

et al. 2013

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The prognosis of patients affected by metastatic renal cell carcinoma (mRCC) has improved markedly with targeted therapies. Unfortunately, 20-25% of the patients are refractory to treatment at the first response assessment and most patients will acquire drug resistance during the treatment. Moreover, current data on the clinical activity of targeted agents in poor risk or non-clear-cell mRCC patients are inconclusive because of the absence of prospective trials. Therefore, there are still several patients in need of new therapeutic approaches to improve clinical outcomes. Kidney cancer is historically considered resistant to chemotherapy on the basis that the results of phase II trials have not always been promising. We carried out a systematic review of both monochemotherapy and polychemotherapy alone or combined with immunotherapy or targeted agents in mRCC to define the state of the art and to evaluate further clinical research fields. All retrospectives, phase I/dose finding, phase II and phase III studies on chemotherapy in mRCC, published in the literature from January 2003 to November 2012, with at least 20 patients enrolled, were evaluated. Although the results of clinical trials have often been disappointing, in selected cases of mRCC, chemotherapy may have a promising antitumor activity, particularly when there are sarcomatoid differentiation features, or in highly progressive disease where the combination of doxorubicine plus gemcitabine or capecitabine has yielded interesting results. Chemotherapy may play a role in mRCC, whereas targeted agents and immunotherapy have not yielded durable and satisfactory results; further studies are needed.

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Phase II study of alpha interferon on renal cell carcinoma. Summary of three collaborative trials

Cited by 120 publications

References 3 publications

A low-dose combination therapy of interleukin-2 and interferon-α is effective for lung metastasis of renal cell carcinoma: a multicenter open study

A low-dose combination therapy of interleukin-2 and interferon-α is effective for lung metastasis of renal cell carcinoma: a multicenter open study

Immunochemotherapy with interleukin-2, interferon- α and 5-fluorouracil for progressive metastatic renal cell carcinoma: a multicenter phase II study

Chemotherapy in metastatic renal cell carcinoma today? A systematic review

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