Randomized, double-blind, placebo-controlled trial comparing the response rates of carmustine, dacarbazine, and cisplatin with and without tamoxifen in patients with metastatic melanoma. National Cancer Institute of Canada Clinical Trials Group.

Rusthoven, James J.; Quirt, Ian; Iscoe, Neill; McCulloch, Peter; James, Katherine; Lohmann, Reinhard; Jensen, Jens‐Ulrik Stæhr; Burdette-Radoux, Susan; Bodurtha, A.; Silver, Hulbert K. B.; Verma, Shailendra; Armitage, George; Zee, Benny; Bennett, Kimberly Statler

doi:10.1200/jco.1996.14.7.2083

Cited by 158 publications

(69 citation statements)

References 7 publications

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“…In fact, previous reports have repeatedly shown that overall survival is higly risk-dependent (Hoffmann et al, 1998;Rusthoven et al, 1996). This is confirmed by our study since we reported that patients with liver metastases had a significantly shorter survival and shorter progression free survival compared to patients without liver metastases.…”

supporting

confidence: 91%

Combination chemotherapy with or without s.c. IL-2 and IFN-α: results of a prospectively randomized trial of the Cooperative Advanced Malignant Melanoma Chemoimmunotherapy Group (ACIMM)

et al. 2002

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The purpose of this randomized trial was to evaluate the efficacy of combination chemoimmunotherapy compared with chemotherapy alone. A total of 124 patients were randomized to receive intravenous cisplatin (35 mg m 72 , days 1 -3), carmustine (150 mg m 72 , day 1, cycles 1 and 3 only), dacarbacine (220 mg m 72 , days 1 -3) and oral tamoxifen (20 mg m 72 , daily) in combination with (n=64) or without (n=60) sequential subcutaneous IL-2 and IFN-a. In those patients who received sequential immunotherapy, each cycle of chemotherapy was followed by outpatient s.c. IL-2 (10610 6 IU m 72 , days 3 -5, week 4; 5610 6 IU m 72 , days 1, 3, 5, week 5) and s.c. IFN-a (5610 6 IU m 72 , day 1, week 4; days 1, 3, 5, week 5). The overall response rate of patients treated with the combination of chemotherapy and IL-2/IFN-a was 34.3% with seven complete responses (10.9%) and 15 partial responses (23.4%). In patients treated with chemotherapy, only, the overall response rate was 29.9% with eight complete responses (13.3%) and 10 partial responses (16.6%). There was no significant difference in median progression free survival (0 months vs 4 months) and in median overall survival (12 months vs 13 months) for combined chemoimmunotherapy and for chemotherapy, respectively.

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supporting

confidence: 91%

Combination chemotherapy with or without s.c. IL-2 and IFN-α: results of a prospectively randomized trial of the Cooperative Advanced Malignant Melanoma Chemoimmunotherapy Group (ACIMM)

et al. 2002

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“…Our study was set up befoXre the results of the recent randomized study reporting a superior response rate for chemotherapy followed by biotherapy (Legha et al, 1996 (Rusthoven et al, 1996). Very few CRs were reported in that trial (< 5%), and none were detected in our chemotherapy-alone group.…”

Section: British Journal Of Cancermentioning

confidence: 99%

Randomized phase II trial of BCDT [carmustine (BCNU), cisplatin, dacarbazine (DTIC) and tamoxifen] with or without interferon alpha (IFN-α) and interleukin (IL-2) in patients with metastatic melanoma

Johnston

Constenla²,

Moore³

et al. 1998

Br J Cancer

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The purpose of this study was to evaluate in a randomized phase II trial the efficacy and toxicity of combination biochemotherapy compared with chemotherapy alone in patients with metastatic melanoma. Sixty-five patients with metastatic melanoma (ECOG performance status 0 or 1) were randomized to receive intravenous BCNU 100 mg m(-2) (day 1, alternate courses), cisplatin 25 mg m(-2) (days 1-3), DTIC 220 mg m(-2) (days 1-3) and oral tamoxifen 40 mg (BCDT regimen) with (n = 35) or without (n = 30) subcutaneous interleukin 2 (IL-2) 18 x 10(6) iu t.d.s. (day - 2), 9 x 10(6) iu b.d. (day - 1 and 0) and interferon 2 alpha (IFN-alpha) 9 MU (days 1-3). Evidence for immune activation was determined by flow cytometric analysis of peripheral blood lymphocytes. Treatment was repeated every 4 weeks up to six courses depending on response. The overall response rate of BCDT with IL-2/IFN-alpha was 23% [95% confidence interval (CI) 10-40%] with one complete response (CR) and seven partial responses (PR), and for BCDT alone 27% (95% CI 12-46%) with eight PRs; the median durations of response were 2.8 months and 2.5 months respectively. Sites of response were similar in both groups. There was no difference between the two groups in progression-free survival or overall survival (median survival 5 months for BCDT with IL-2/IFNalpha and 5.5 months for BCDT alone). Although 3 days of subcutaneous IL-2 resulted in significant lymphopenia, evidence of immune activation was indicated by a significant rise in the percentage of CD56- (NK cells) and CD3/HLA-DR-positive (activated T cells) subsets, without any change in the percentage of CD4 or CD4 T-cell subsets. Toxicity assessment revealed a significantly higher incidence of severe thrombocytopenia in patients treated with combination chemotherapy than with chemotherapy alone (37% vs 13%, P = 0.03) and a higher incidence of grade 3/4 flu-like symptoms (20% vs 10%) and fatigue (26% vs 13%). The addition of subcutaneous IL-2 and IFNalpha to BCDT chemotherapy in a randomized phase II trial resulted in immune activation but did not improve response rates in patients with metastatic melanoma, and indeed may increase some treatment-related toxicity.

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“…One patient on Schedule B reported that she was ceasing treatment after 43 days because of out tamoxifen, but without interferon-a. 6 nausea, vomiting, and malaise. Even though the protocol would not have required tumor measurements unSurvival Failure free and overall survival for all patients entil Week 9, a scan on Day 47 did show PD in her liver; thus, she was considered to have PD.…”

Section: Resultsmentioning

confidence: 99%

Interferon-α and chemohormonal therapy for patients with advanced melanoma

Stark¹,

Dillman

Schulof

et al. 1998

Cancer

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Randomized, double-blind, placebo-controlled trial comparing the response rates of carmustine, dacarbazine, and cisplatin with and without tamoxifen in patients with metastatic melanoma. National Cancer Institute of Canada Clinical Trials Group.

Abstract: These results demonstrate that the addition of high doses of tamoxifen to this chemotherapy regimen does not increase the response rate compared with chemotherapy alone in unselected patients with metastatic melanoma.

Cited by 158 publications

References 7 publications

Combination chemotherapy with or without s.c. IL-2 and IFN-α: results of a prospectively randomized trial of the Cooperative Advanced Malignant Melanoma Chemoimmunotherapy Group (ACIMM)

Combination chemotherapy with or without s.c. IL-2 and IFN-α: results of a prospectively randomized trial of the Cooperative Advanced Malignant Melanoma Chemoimmunotherapy Group (ACIMM)

Randomized phase II trial of BCDT [carmustine (BCNU), cisplatin, dacarbazine (DTIC) and tamoxifen] with or without interferon alpha (IFN-α) and interleukin (IL-2) in patients with metastatic melanoma

Interferon-α and chemohormonal therapy for patients with advanced melanoma

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