Phase II Trial of Weekly Intravenous Gemcitabine Administration With Interferon and Interleukin-2 Immunotherapy for Metastatic Renal Cell Cancer

Neri, B; Doni, Laura; Gemelli, M T; Fulignati, C; Turrini, Mauro; Cello, V. Di; Dominici, A; Maleci, M.; Mottola, A; Ponchietti, Roberto; Raugei, A.; Valsuani, G.; Cini, G

doi:10.1016/s0022-5347(05)64550-8

Cited by 23 publications

(2 citation statements)

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“…14,18 At least two other gemcitabine-based Phase II studies have reported higher response rates (31% in a single-agent feasibility study 15 and 28% for the combination of gemcitabine, IL-2, and interferon-␣. 17 ) than the one noted in the current study. However, the small number of patients enrolled in those studies (16 and 18, respectively) may be indicative of a relevant bias.…”

Section: Discussioncontrasting

confidence: 54%

“…10 More recently, it has been shown that gemcitabine-containing combinations also exert some antitumor activity in patients with immunotherapy-resistant advanced RCC. [11][12][13][14][15][16][17][18][19][20] Herein, we report the results of a single-institution Phase II study in which we evaluated the antitumor activity and toxicity of a combination of gemcitabine with the platinum derivative oxaliplatin (L-OHP).…”

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confidence: 99%

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Gemcitabine and oxaliplatin in the treatment of patients with immunotherapy‐resistant advanced renal cell carcinoma

Porta

Zimatore

Imarisio

et al. 2004

Cancer

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BACKGROUNDCurrently, there is no standard treatment for patients with advanced renal cell carcinoma (RCC) who do not experience a response to first‐line immunotherapy. In the current Phase II study, the authors explored the antitumor activity of a combination of gemcitabine and oxaliplatin (L‐OHP) in this setting.METHODSForty‐two patients with RCC who had progressive disease following immunotherapy received gemcitabine (1000 mg/m2 intravenously on Days 1 and 8 every 21 days) and L‐OHP (90 mg/m2 intravenously on Day 1 every 21 days) for a minimum of 2 cycles before responses were evaluated. Responses to treatment and toxicity were recorded according to the Response Evaluation Criteria in Solid Tumors and the National Cancer Institute Common Toxicity Criteria, respectively.RESULTSNo complete responses were recorded; however, 6 patients experienced a partial response (14.28%; 95% confidence interval, 5.43–28.5%), 11 patients (26.19%) had temporary stable disease as a best response, and the remaining 25 patients (59.52%) experienced progression despite receiving treatment. The median time to disease progression was 2.5 months (mean, 3.86 months; range, 1.5–11.0 months), whereas the median overall survival was 9.5 months (mean, 10.46 months; range, 4.0–22.5 months). With regard to toxicity, treatment generally was well tolerated, with only one episode of Grade 4 toxicity and expected episodes of Grade 3 toxicity, including myelosuppression and neuropathy.CONCLUSIONSThe current results suggest that the combination of gemcitabine and L‐OHP possesses a certain level of activity and an acceptable toxicity profile in patients with immunotherapy‐resistant advanced RCC. Cancer 2004. © 2004 American Cancer Society.

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confidence: 54%

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Gemcitabine and oxaliplatin in the treatment of patients with immunotherapy‐resistant advanced renal cell carcinoma

Porta

Zimatore

Imarisio

et al. 2004

Cancer

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Active chemotherapy for sarcomatoid and rapidly progressing renal cell carcinoma

Nanus

Garino

Milowsky

et al. 2004

Cancer

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109

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BACKGROUND Immunotherapy is generally ineffective in patients with sarcomatoid renal cell carcinoma (RCC) and in patients with rapidly progressive metastatic or locally recurrent disease, with a median time to progression of approximately 2 months and a median survival of 4–7 months. Gemcitabine‐based regimens have modest antitumor activity, whereas doxorubicin is often used to treat sarcomatoid RCC. Based on the antitumor activity of doxorubicin and gemcitabine in collecting duct carcinoma of the kidney, the authors used this combination to treat selected patients with sarcomatoid or rapidly progressing RCC. METHODS Eighteen patients (11 males and 7 females; median age, 53 years; range, 31–81 years) with RCC (56% sarcomatoid; 44% other) were treated at 2 institutions in a collaborative study that was not institutional review board reviewed. Seven patients received previous treatment with interferon or interleukin‐2. Sites of metastases included the lung, soft tissue, bone, liver, and brain with 88% of patients having ≥ 3 sites of disease. Treatment consisted of doxorubicin (50 mg/m2) and gemcitabine (1500 or 2000 mg/m2) every 2–3 weeks with granulocyte–colony‐stimulating factor support. RESULTS A median of 5 courses was administered (range, 2–12 cycles). Therapy was well tolerated with no Grade 4 toxicities. Two patients had a complete response, five had a partial response, three had a mixed response, and one had stable disease. The median duration of response was 5 months (range, 2–21+ months). CONCLUSIONS These data suggested that the combination of doxorubicin and gemcitabine has antitumor activity in patients with sarcomatoid RCC or with rapidly progressing RCC. A prospective investigation of this combination in RCC is warranted. Cancer 2004. © 2004 American Cancer Society.

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Combination Cytokine Therapy

Cohen

Kaufman

Cancer Drug Discovery and Development

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Phase II Trial of Weekly Intravenous Gemcitabine Administration With Interferon and Interleukin-2 Immunotherapy for Metastatic Renal Cell Cancer

Cited by 23 publications

References 13 publications

Gemcitabine and oxaliplatin in the treatment of patients with immunotherapy‐resistant advanced renal cell carcinoma

Gemcitabine and oxaliplatin in the treatment of patients with immunotherapy‐resistant advanced renal cell carcinoma

Active chemotherapy for sarcomatoid and rapidly progressing renal cell carcinoma

Combination Cytokine Therapy

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