Assessment of absolute lymphocyte count (ALC) as a predictor of progression-free survival (PFS) and overall response rate (ORR) in metastatic melanoma (MM) patients (pts) treated with high-dose interleukin-2 (HD IL-2).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9096-9096
Author(s):  
Jeffrey Thomas Yorio ◽  
Patricia S Fox ◽  
Richard Wayne Joseph ◽  
Roland Bassett ◽  
Michael A. Davies
Keyword(s):  
Metastatic Melanoma ◽  
Clinical Benefit ◽  
Hematological Parameters ◽  
Interleukin 2 ◽  
Progression Free Survival ◽  
Absolute Lymphocyte Count ◽  
Cancer Center ◽  
High Dose ◽  
Continuous Variables ◽  
Significant Difference

9096 Background: HD IL-2 is an approved immunotherapy that can achieve durable cures in MM pts. Due to toxicity and low ORR, identification of predictors of clinical benefit would enhance pt selection and outcomes with HD IL-2. Recent research identified a positive correlation for ALC ≥ 1000 (either at baseline or at dose 3) with OS among MM pts treated with the immunotherapy agent ipilimumab. We tested the hypothesis that ALC (≥ 1000) or other hematological parameters correlates with clinical benefit from HD IL2. Methods: Results of hematologic testing in patients (n=98) treated with HD IL2 at MD Anderson Cancer Center were collected, including absolute levels of neutrophils (ANC), lymphocytes (ALC), monocytes (AMC), eosinophils (AEC), and platelets (APC) at baseline, after cycle 1 (C1), and after cycle 2 (C2) of HD IL-2; changes in each parameter for each interval were also calculated. Hematologic values were assessed as categorical (for ALC, ≥ 1000 Yes/No; other parameters, above upper limit of normal [ULN] Yes/No) and continuous variables. Associations between these parameters and PFS and ORR were analyzed. Results: ALC was≥ 1000 in 75 pts (76%) at baseline, in 81 (83%) after C1, and in 80 of 86 pts (93%) after completion of C2 of HD IL-2. PFS was not significantly associated with ALC ≥ 1000 at baseline (HR 0.69, p=0.13), after C1 (HR 1.32, p=0.33), or after C2 (HR 1.01, p=0.98). ALC ≥ 1000 at each timepoint was not significantly associated with ORR or OS. There was no significant difference in the change in ALC with HD IL2 treatment among responders versus non-responders. Among baseline hematological factors, APC > ULN was significantly associated with PFS (p=0.001), but it was rare (2/98 patients). Exploratory analyses identified significantly shorter PFS for patients with baseline APC > 300 (11%, HR 2.75, p=0.002). Analysis of hematologic factors as continuous values identified significant associations with PFS for AMC (HR 2.42, p=0.03) and AEC (HR 1.73, p=0.009) after C2. Conclusions: ALC ≥ 1000 did not correlate with PFS, ORR, or OS with HD IL-2 therapy in this cohort of metastatic melanoma pts.

Dacarbazine, Cisplatin, and Interferon-Alfa-2b With or Without Interleukin-2 in Metastatic Melanoma: A Randomized Phase III Trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group

2005 ◽  
Vol 23 (27) ◽  
pp. 6747-6755 ◽  
Author(s):  
Ulrich Keilholz ◽  
Cornelis J.A. Punt ◽  
Martin Gore ◽  
Wim Kruit ◽  
Poulam Patel ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Single Agent ◽  
Interleukin 2 ◽  
Progression Free Survival ◽  
Interferon Alfa ◽  
Phase Iii ◽  
High Dose ◽  
Phase Iii Trial ◽  
Significant Difference ◽  
To Receive

Background Based on phase II trial results, chemoimmunotherapy combinations have become the preferred treatment for patients with metastatic melanoma in many institutions. This study was performed to determine whether interleukin-2 (IL-2) as a component of chemoimmunotherapy influences survival of patients with metastatic melanoma. Patients and Methods Patients with advanced metastatic melanoma were randomly assigned to receive dacarbazine 250 mg/m2 and cisplatin 30 mg/m2 on days 1 to 3 combined with interferon-alfa-2b 10 × 106 U/m2 subcutaneously on days 1 through 5 without (arm A) or with (arm B) a high-dose intravenous decrescendo regimen of IL-2 on days 5 through 10 (18 × 106 U/m2/6 hours, 18 × 106 U/m2/12 hours, 18 × 106 U/m2/24 hours, and 4.5 × 106 U/m2 for 3 × 24 hours). Treatment cycles were repeated in the absence of disease progression every 28 days to a maximum of four cycles. Results Three hundred sixty-three patients with advanced metastatic melanoma were accrued. The median survival was 9 months in both arms, with a 2-year survival rate of 12.9% and 17.6% in arms A and B, respectively (P = .32; hazard ratio, 0.90; 95% CI, 0.72 to 1.11). There was also no statistically significant difference regarding progression-free survival (median, 3.0 v 3.9 months) and response rate (22.8% v 20.8%). Conclusion Despite its activity in melanoma as a single agent or in combination with interferon-alfa-2b, the chosen schedule of IL-2 added to the chemoimmunotherapy combination had no clinically relevant activity.

scholarly journals Long-term progression-free survival of patients with metastatic melanoma or renal cell carcinoma following high-dose interleukin-2

2021 ◽  
Vol 69 (4) ◽  
pp. 888-892
Author(s):  
Joseph I Clark ◽  
Brendan Curti ◽  
Elizabeth J Davis ◽  
Howard Kaufman ◽  
Asim Amin ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Melanoma ◽  
Systemic Therapy ◽  
Renal Cell ◽  
Interleukin 2 ◽  
Progression Free Survival ◽  
High Dose ◽  
Free Survival

High-dose interleukin-2 (HD IL-2) was approved in the 1990s after demonstrating durable complete responses (CRs) in some patients with metastatic melanoma (mM) and metastatic renal cell carcinoma (mRCC). Patients who achieve this level of disease control have also demonstrated improved survival compared with patients who progress, but limited data are available describing the long-term course. The aim of this study was to better characterize long-term survival following successful HD IL-2 treatment in patients with no subsequent systemic therapy. Eleven HD IL-2 treatment centers identified patients with survival ≥5 years after HD IL-2, with no subsequent systemic therapy. Survival was evaluated from the date of IL-2 treatment to June 2017. Treatment courses consisted of 2 1-week cycles of HD IL-2. Patients were treated with HD IL-2 alone, or HD IL-2 followed by local therapy to achieve maximal response. 100 patients are reported: 54 patients with mM and 46 patients with mRCC. Progression-free survival (PFS) after HD IL-2 ranges from 5+ years to 30+ years, with a median follow-up of 10+ years. 27 mRCC and 32 mM are alive ≥10 years after IL-2. Thus, a small subset of patients with mM and mRCC achieve long-term PFS (≥5 years) after treatment with HD IL-2 as their only systemic therapy. The ability of HD IL-2 therapy to induce prolonged PFS should be a major consideration in studies of new immunotherapy combinations for mM and mRCC.

Clinical benefit (CB) of high-dose interleukin-2 (HD IL-2) in clear cell (cc) metastatic renal cell carcinoma (mRCC).

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 461-461
Author(s):  
Neeraj Agarwal ◽  
Kinjal Parikh ◽  
Srinivas Kiran Tantravahi ◽  
Hilda Crispin ◽  
Joan Van Atta ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Clear Cell ◽  
Objective Response ◽  
Interleukin 2 ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Complete Response ◽  
High Dose ◽  
Select Group ◽  
Best Response

461 Background: HD IL-2, an immunotherapy, is a standard of care for a select group of patients (pts) with mRCC. Generally objective response (OR) rates, i.e. complete response (CR) + partial response (PR), of 16-20% are discussed with pts, but not disease stabilization (SD). Recent data suggest that cancer immunotherapy may improve survival without inducing OR. Thus, treatment with HD IL-2 may provide survival benefit to an additional group of pts not experiencing OR, but only SD as the best response. Here we report CB ( OR+SD), and specifically report outcomes of cc mRCC pts experiencing SD as the best response, on treatment with HD IL-2. Methods: All sequential cc mRCC pts treated with HD IL-2 at the University of Utah Huntsman Cancer Institute from 2000-2012 were included. Pts were evaluated for best response, progression-free survival (PFS), time to next treatment (TNT) and overall survival (OS). Two practitioners independently reviewed HD IL-2 response with discrepancies adjudicated by a third reviewer. Results: 85 pts, 79% male, were identified with a median age of 56 (range 32-76) years. Pts belonged to the following MSKCC risk categories: 11 (13%) good, 70 (82%) intermediate, and 4 (5%) poor risk. A CR was identified in 9 (11%), PR in 5 (6%), SD in 26 (31%), progressive disease (PD) in 38 (45%), and unknown/not evaluable (NE) in 7 (8%) pts; yielding a clinical benefit in 40 (47%) pts. The median PFS, TNT, and OS in these individual groups of pts are compared in the table. Conclusions: A clinical benefit of HD IL-2 was achieved in nearly half of all clear cell mRCC pts. OS was not significantly different in OR and SD groups. Even though OR favorably determine outcomes, SD is also an important response criterion, and may be discussed during counseling pts for treatment with HD IL-2. [Table: see text]

scholarly journals Interferon alfa-2a and interleukin-2 with or without cisplatin in metastatic melanoma: a randomized trial of the European Organization for Research and Treatment of Cancer Melanoma Cooperative Group.

1997 ◽  
Vol 15 (7) ◽  
pp. 2579-2588 ◽  
Author(s):  
U Keilholz ◽  
S H Goey ◽  
C J Punt ◽  
T M Proebstle ◽  
R Salzmann ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Response Rate ◽  
Interleukin 2 ◽  
Progression Free Survival ◽  
Interferon Alfa ◽  
Survival Duration ◽  
High Dose ◽  
Free Survival ◽  
Ifn Alpha ◽  
Cytokine Treatment

PURPOSE The combination of interferon alfa-2a (IFN alpha) and high-dose interleukin-2 (IL-2) is active in metastatic melanoma. The addition of cisplatin (CDDP) has resulted in response rates greater than 50%. This study was performed to determine whether the addition of CDDP to a cytokine treatment regimen with IFN alpha and high-dose IL-2 influences survival of patients with metastatic melanoma. PATIENTS AND METHODS Patients with advanced metastatic melanoma were randomly assigned to receive treatment with IFN alpha 10 x 10(6) U/m2 subcutaneously on days 1 through 5 and a high-dose intravenous decrescendo regimen of IL-2 on days 3 through 8 (18 mIU/ m2/6 hours, 18 mIU/m2/12 hours, 18 mIU/m2/24 hours, and 4.5 mIU/m2/24 hours x 3) without (arm A) or with (arm B) CDDP 100 mg/m2 on day 1. Treatment cycles were repeated every 28 days to a maximum of four cycles. RESULTS One hundred thirty-eight patients with advanced metastatic melanoma, of whom 87% had visceral metastases, were accrued for the trial. Both regimens were feasible in a multicenter setting. The objective response rate was 18% without and 33% with CDDP (P = .04). The progression-free survival was 53 days without and 92 days with CDDP (P = .02, Wilcoxon; P = .09, log-rank). There was no statistically significant difference in survival between treatment arms, with a median overall survival duration for all patients of 9 months. CONCLUSION The addition of CDDP to cytokine treatment with IFN alpha and IL-2 does not influence survival of patients with advanced metastatic melanoma, despite a significant increase in response rate and progression-free survival.

Role of Brain-Type Natriuretic Peptide and Cardiac Troponins as Predictors of Outcome in Multiple Myeloma

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4457-4457
Author(s):  
Ebru Koca ◽  
Gaurav Parikh ◽  
Ali Imran Amjad ◽  
Floralyn L Mendoza ◽  
Chitra M Hosing ◽  
...  
Keyword(s):  
Overall Survival ◽  
Natriuretic Peptide ◽  
Prognostic Markers ◽  
Progression Free Survival ◽  
High Dose Chemotherapy ◽  
Cancer Center ◽  
High Dose ◽  
Cardiac Events ◽  
Significant Difference ◽  
Cardiac Troponins

Abstract BACKGROUND: High circulating levels of cardiac troponins, T and I (cTnT and cTnI) and brain-type natriuretic peptide (BNP) are associated with shorter overall survival and increased transplant-related mortality (TRM) in patients with amyloidosis undergoing high-dose chemotherapy and autologous stem cell transplantation (auto SCT). Their role as prognostic markers in myeloma is not clearly defined. We evaluated the utility of BNP, cTnT and cTnI as prognostic markers in patients undergoing auto SCT for myeloma. METHODS: We retrospectively analyzed patients who received high-dose chemotherapy followed by auto SCT at MD Anderson Cancer Center between January 1 and December 31, 2006. Pre auto SCT levels of BNP, cTnT and cTnI were available in all patients. The upper limit of BNP was 100 ng/L, cTnT 0.01 ng/ml and cTnI 0.03 ng/ml. RESULTS: A total of 105 patients (68 male and 37 female) with a median age of 57 (31–73) received auto SCT during the study period. Seventy-seven patients received high-dose melphalan 200 mg/m2 as preparative regimen, while 28 patients received a combination of melphalan 140 mg/m2 + busulfan 130 mg/m2 × 4 days. Median follow up of surviving patients was 21 months (1–30). Twenty-four (23%) patients had a high BNP level (>100 ng/L) prior to transplantation, 7 patients had a high cTnT level (>0.01ng/ml) and 12 patients had a high cTnI level (>0.03 ng/ml). In 101 evaluable patients, responses (complete 22 + partial 53) were seen in 75 (74%) patients. Overall survival (OS) and progression-free survival (PFS) at 24 months was 86 and 58%, respectively. There was no significant difference in 24-month OS in the high BNP group (p=0.7). Eight patients died of non-relapse causes, with only one death in patients with high BNP (p=0.67). Grade 3–4 cardiac adverse events were reported in 2 patients only, one of whom had elevated BNP (p=0.54). An increase in either BNP, cTnT or cTNI was seen in 30 patients. These patients did not have a significant increase in TRM (p=0.68) or cardiac toxicity, or a decrease in OS. CONCLUSION: High pretransplant levels of BNP, cTnT or cTnI levels, either individually or together, did not adversely impact cardiac events, TRM or OS.

Durable Complete Responses With High-Dose Bolus Interleukin-2 in Patients With Metastatic Melanoma Who Have Experienced Progression After Biochemotherapy

2007 ◽  
Vol 25 (25) ◽  
pp. 3802-3807 ◽  
Author(s):  
Ahmad A. Tarhini ◽  
John M. Kirkwood ◽  
William E. Gooding ◽  
Chao Cai ◽  
Sanjiv S. Agarwala
Keyword(s):  
Survival Time ◽  
Metastatic Melanoma ◽  
Interleukin 2 ◽  
Rest Period ◽  
Dose Intensity ◽  
Progression Free Survival ◽  
Initial Response ◽  
Disease Stage ◽  
High Dose ◽  
Ajcc Stage

Purpose We conducted a phase II trial of high-dose bolus (HDB) interleukin-2 (IL-2) in patients with metastatic melanoma who had experienced progression after biochemotherapy (BCT). Patients and Methods Eligible patients had experienced progression on or after BCT (cisplatin, vinblastine, dacarbazine, IL-2 9 MU/m2/d for 4 days, and interferon alfa-2b). HDB IL-2 was administered at 600,000 U/kg per dose for a maximum of 14 doses per cycle with a 1-week rest period between cycles. Stable or responding patients were offered an additional course (two cycles) after 6 to 8 weeks. Results Twenty-six patients (12 men and 14 women), age 28 to 70 years (median, 45 years), have been treated. All but three patients received at least two cycles of HDB IL-2; 10 patients received a second course of therapy. Disease stage was American Joint Committee on Cancer (AJCC) stage M1a (n = 5), M1b (n = 5), and M1c (n = 16). Grade 3 and 4 toxicities included hyperbilirubinemia (n = 10), thrombocytopenia (n = 6), oliguria (n = 3), diarrhea (n = 1), infection (n = 2), and neurologic toxicity (n = 2). Overall response rate was 19.2% (four complete responses, lasting 4, 4, 26+, and 41+ months; and one partial response, lasting 3 months). Five patients (19%) had stable disease lasting 1 to 3 months, but all eventually experienced progression. All four complete responders had AJCC stage M1a disease. At a median follow-up time of 10 months, median survival time was 42 weeks (95% CI, 19.1 to 86.6 weeks), and median progression-free survival time was 10 weeks (95% CI, 8 to 16.1 weeks). An initial response to BCT was not found to be predictive for response to HDB IL-2. Conclusion HDB IL-2 is active therapy for patients who experience progression on BCT. This observation has implications regarding the importance of dose-intensity for IL-2 therapy.

Factors Associated With Response to High-Dose Interleukin-2 in Patients With Metastatic Melanoma

2001 ◽  
Vol 19 (15) ◽  
pp. 3477-3482 ◽  
Author(s):  
Giao Q. Phan ◽  
Peter Attia ◽  
Seth M. Steinberg ◽  
Donald E. White ◽  
Steven A. Rosenberg
Keyword(s):  
Metastatic Melanoma ◽  
Objective Response ◽  
Interleukin 2 ◽  
Thyroid Stimulating Hormone ◽  
High Dose ◽  
Thyroid Function Tests ◽  
Free T4 ◽  
Prior Therapy ◽  
Patient Demographics ◽  
Significant Difference

PURPOSE: The present study attempted to identify characteristics that correlated with clinical response to interleukin (IL)-2 therapy in patients with metastatic melanoma. PATIENTS AND METHODS: We retrospectively evaluated laboratory and clinical characteristics of 374 consecutive patients with metastatic melanoma treated with high-dose intravenous bolus IL-2 (720,000 IU/kg) from July 1, 1988, to December 31, 1999, at the Surgery Branch of the National Cancer Institute. RESULTS: The overall objective response rate was 15.5%. Pretreatment parameters such as patient demographics, laboratory values, and prior therapy did not correlate with response; however, 53.6% of patients with only subcutaneous and/or cutaneous metastases responded, compared with 12.4% of patients with disease at other sites (P2 = .000001). During therapy, patients who were responders tended to have received more doses during course 1 (16.2 ± 0.3 doses v 14.5 ± 0.2 doses; P2 = .0095); however, when limited to patients who were able to complete both cycles of course 1, there was no statistically significant difference (P2 = .27). Responders had a higher maximum lymphocyte count immediately after therapy compared with nonresponders (P2 = .0026). The development of abnormal thyroid function tests and vitiligo after therapy was associated with response (thyroid-stimulating hormone, P2 = .01; free T4, P2 = .0049; vitiligo, P2 < 10−6), although thyroid dysfunction may have been related more to the length of IL-2 therapy than to response. CONCLUSION: The presence of metastases only to subcutaneous and/or cutaneous sites, lymphocytosis immediately after treatment, and long-term immunologic side effects, especially vitiligo, were associated with antitumor response to IL-2 therapy.

scholarly journals The predictive value of absolute lymphocyte counts on tumor progression and pseudoprogression in patients with glioblastoma

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jing Xi ◽  
Bilal Hassan ◽  
Ruth G. N. Katumba ◽  
Karam Khaddour ◽  
Akshay Govindan ◽  
...  
Keyword(s):  
Tumor Progression ◽  
Predictive Value ◽  
Absolute Lymphocyte Count ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Current Standard ◽  
Surgical Biopsy ◽  
Cell Counts ◽  
Significant Difference ◽  
True Progression

Abstract Background Differentiating true glioblastoma multiforme (GBM) from pseudoprogression (PsP) remains a challenge with current standard magnetic resonance imaging (MRI). The objective of this study was to explore whether patients’ absolute lymphocyte count (ALC) levels can be utilized to predict true tumor progression and PsP. Methods Patients were considered eligible for the study if they had 1) GBM diagnosis, 2) a series of blood cell counts and clinical follow-ups, and 3) tumor progression documented by both MRI and pathology. Data analysis results include descriptive statistics, median (IQR) for continuous variables and count (%) for categorical variables, p values from Wilcoxon rank sum test or Fisher’s exact test for comparison, respectively, and Kaplan-Meier analysis for overall survival (OS). OS was defined as the time from patients’ second surgery to their time of death or last follow up if patients were still alive. Results 78 patients were included in this study. The median age was 56 years. Median ALC dropped 34.5% from baseline 1400 cells/mm3 to 917 cells/mm3 after completion of radiation therapy (RT) and temozolomide (TMZ). All study patients had undergone surgical biopsy upon MRI-documented progression. 37 had true tumor progression (47.44%) and 41 had pseudoprogression (52.56%). ALC before RT/TMZ, post RT/TMZ and at the time of MRI-documented progression did not show significant difference between patients with true progression and PsP. Although not statistically significant, this study found that patients with true progression had worse OS compared to those with PsP (Hazard Ratio [HR] 1.44, 95% CI 0.86–2.43, P = 0.178). This study also found that patients with high ALC (dichotomized by median) post-radiation had longer OS. Conclusion Our results indicate that ALC level in GBM patients before or after treatment does not have predictive value for true disease progression or pseudoprogression. Patients with true progression had worse OS compared to those who had pseudoprogression. A larger sample size that includes CD4 cell counts may be needed to evaluate the PsP predictive value of peripheral blood biomarkers.

Complete regression of subcutaneous and cutaneous metastatic melanoma with high-dose intralesional interleukin 2 in combination with topical imiquimod and retinoid cream

2011 ◽  
Vol 21 (3) ◽  
pp. 235-243 ◽  
Author(s):  
Miki Shirakawa Garcia ◽  
Yoko Ono ◽  
Steve R. Martinez ◽  
Steven L. Chen ◽  
Heidi Goodarzi ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Interleukin 2 ◽  
High Dose ◽  
Complete Regression ◽  
Topical Imiquimod

Interleukin-2 and high-dose cisplatin in patients with metastatic melanoma: a pilot study.

1991 ◽  
Vol 9 (10) ◽  
pp. 1821-1830 ◽  
Author(s):  
P A Demchak ◽  
J W Mier ◽  
N J Robert ◽  
K O'Brien ◽  
J A Gould ◽  
...  
Keyword(s):  
Pilot Study ◽  
Metastatic Melanoma ◽  
Response Rate ◽  
Tumor Regression ◽  
Interleukin 2 ◽  
Tumor Burden ◽  
High Dose ◽  
Minor Response ◽  
Exact Test ◽  
Combined Immunotherapy

In this pilot study of metastatic melanoma, interleukin-2 (IL-2) and cisplatin (CDDP) chemotherapy were combined using an alternating schedule designed to explore potential synergism between these modalities. Bolus IL-2 was given at a dose of 600,000 IU/kg intravenously (IV) every 8 hours, days 1 to 5 and 15 to 19, followed by high-dose CDDP administered by two different regimens: (A) 135 to 150 mg/m2 IV bolus over 30 minutes with the chemoprotectant WR-2721 910 mg/m2 or (B) 50 mg/m2 IV over 2 hours every day for 3 days. The trial design allowed an assessment of response to each phase of therapy. Among 27 assessable patients, there were 10 (37%) overall responses, including three (11%) complete responses (CRs) with durations of 9, 16, and 30+ months. Tumor regression was noted in seven patients (partial response [PR], four; minor response [MR], three; response rate [RR], four of 27 [15%]) after IL-2 administration and in 14 patients (PR, 12; MR, two; RR, 12 of 27 [44%]) after CDDP treatment, demonstrating noncrossresistance between the components of the regimen. Major PRs (greater than 90% reduction of tumor burden) or CRs were only seen in patients responding to IL-2. Toxicity during IL-2 therapy was typical for high-dose IL-2 protocols and was reversible. Among the first 20 patients treated with CDDP regimen A, there were eight episodes of grade IV nephrotoxicity (creatinine level greater than 5.0 mg/dL), including three of six patients treated with an initial CDDP dose of 135 mg/m2. This side effect was more frequent among patients with liver metastasis (P less than .05, Fisher's exact test). No significant nephrotoxicity was noted in seven patients treated on regimen B. Although ototoxicity was frequent, minimal bone marrow and neurologic toxicity was noted. There were no treatment-related deaths. This combination showed at least additive activity against melanoma, and the more protracted CDDP schedule was well tolerated. This regimen may serve as a model for future combined immunotherapy and chemotherapy trials in metastatic melanoma.

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