Outpatient treatment with subcutaneous interleukin-2 and interferon alfa administration in combination with fluorouracil in patients with metastatic renal cell carcinoma: results of a sequential nonrandomized phase II study. Subcutaneous Administration Propeukin Program Cooperative Group.

Tourani, Jean-Marc; Pfister, C.; Berdah, J.F.; Benhammouda, A.; Salze, Paul; Monnier, Alain; Paule, Bernard; Guillet, Pierre; Chrétien, Yves; Brewer, Y.; Palma, Mario Di; Untereiner, M.; Malaurie, E.; Tadrist, Z; Pavlovitch, J. M.; Hauteville, D.; Méjean, Arnaud; Azagury, M; Mayeur, Didier; Lucas, Virginie; Krakowski, I.; Larregain-Fournier, D.; Abourachid, H; Andrieu, J; Chastang, Claude

doi:10.1200/jco.1998.16.7.2505

Cited by 69 publications

(21 citation statements)

References 23 publications

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“…It is difficult to compare our group of patients with that of Atzpodien et al, due to the use of a different prognostic system (Atzpodien et al, 1993b). When compared with others, our group showed more favourable prognostic factors than the patients reported by Joffe, but was similar to the group reported by Tourani (Joffe et al, 1996;Tourani et al, 1998).…”

Section: Discussioncontrasting

confidence: 40%

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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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Section: Discussioncontrasting

confidence: 40%

“…infusion and/or the drugs were administered all three concomitantly. The response rates were 39, 31, 8, 20, 2 and 35% respectively for the reports by Sella et al (1994), Ellerhorst et al (1997), Negrier et al (1997), Tourani et al (1998), Ravaud et al (1998) and Ventriglia et al, (1998) (Table 3).…”

Section: Discussionmentioning

confidence: 77%

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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“…However, some patients have good quality responses with prolonged disease-free survival, and for this reason immunotherapy has remained the standard first-line treatment for this disease (Medical Research Council Renal Cancer Collaborators, 1999). Combinations of immunotherapy and 5-fluorouracil (5-FU) chemotherapy have produced consistently higher response rates of 20 -39% in previously untreated patients, but at the expense of additional toxicity Lopez Hanninen et al, 1995;Tourani et al, 1998;Allen et al, 2000;van Herpen et al, 2000). As yet there is no randomised evidence supporting the superiority of this approach over standard immunotherapy.…”

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confidence: 99%

Phase II clinical trial of capecitabine and gemcitabine chemotherapy in patients with metastatic renal carcinoma

et al. 2004

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“…This is a statistical literature analysis based upon 80 publications of treatment of RCCa with IL-2 alone, in combination with other agents, or with LAK cells [12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92]. Reports were identified from citations in recent complete publications and from a Medline search through July 1999.…”

Section: Methodsmentioning

confidence: 99%

A Literature Analysis of Prognostic Factors for Response and Quality of Response of Patients with Renal Cell Carcinoma to Interleukin-2-Based Therapy

Elias

Hunt²

2001

Oncology

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Objective: To characterize prognostic factors for response of advanced renal cell carcinoma to interleukin-2-based regimens. Patients and Methods: Data compiled from 80 published series were examined for associations between patient characteristics and outcomes. Results: Response rates were highest in trials utilizing interleukin-2 combinations. Longer median survivals were associated with high percentages of patients with nephrectomy, good performance status, with publication year, response rates, and inversely with median ages. Associations of performance status and prior nephrectomy with response rates were detected in trials with individual patient details. The response rate was higher for patients older than the median age of patients entering each trial, and also higher for males. Among responders, attainment of complete response was associated with fewer sites of involvement. Pooled response duration of patients reported to have complete responses exhibited durability, but no correlation with prognostic factors. Selection factors may have influenced apparent differences between types of regimens. We confirm the potential for durable remissions from interleukin-2-based regimens.

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Outpatient treatment with subcutaneous interleukin-2 and interferon alfa administration in combination with fluorouracil in patients with metastatic renal cell carcinoma: results of a sequential nonrandomized phase II study. Subcutaneous Administration Propeukin Program Cooperative Group.

Cited by 69 publications

References 23 publications

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

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

Phase II clinical trial of capecitabine and gemcitabine chemotherapy in patients with metastatic renal carcinoma

A Literature Analysis of Prognostic Factors for Response and Quality of Response of Patients with Renal Cell Carcinoma to Interleukin-2-Based Therapy

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