Phase I/II Study of a Cisplatin-Taxol-Dacarbazine Regimen in Metastatic Melanoma

Papadopoulos, Nicholas E.; Bedikian, Agop Y.; Ring, Sigrid; Kim, Kevin B.; Hwu, Wen Jen; Gerber, Donna L.; Homsi, Jade; Hwu, Patrick

doi:10.1097/coc.0b013e3181942a1f

Cited by 18 publications

(16 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…trials were identified and reviewed. [9][10][11][12][13][14][15][16][17][18][19][20] These included 2 trials of neoadjuvant therapy for regional metastases, 1 trial of adjuvant therapy, and 9 trials for metastatic melanoma. We identified 330 (44%) patients who developed brain metastases at some point during the course of their disease.…”

Section: Resultsmentioning

confidence: 99%

Prognostic factors for survival in melanoma patients with brain metastases

Davies

Liu

McIntyre

et al. 2010

Cancer

Self Cite

472

358

View full text Add to dashboard Cite

BACKGROUND:One of the most common and deadly complications of melanoma is brain metastases. The outcomes of advanced melanoma patients who developed brain metastases were reviewed to identify significant prognostic factors for overall survival (OS). METHODS: An institutional database of advanced melanoma patients enrolled on clinical trials in the Department of Melanoma Medical Oncology from 1986 to 2004 was reviewed and patients who developed brain metastases were identified. Date of diagnosis, patient age, pattern of brain involvement, timing relative to extracranial metastases, prior response to systemic therapy, and treatments given for brain metastases were assessed as potential prognostic factors for OS. RESULTS: Among 743 melanoma patients enrolled in clinical trials for regional or systemic metastatic disease, 330 (44%) patients developed brain metastases. The median OS after the diagnosis of brain metastases was 4.7 months. Diagnosis before 1996, increased number of parenchymal brain metastases, leptomeningeal involvement, and development of brain metastases after receiving systemic therapy for extracranial metastases were found to be significant prognostic factors for OS. Among patients who received systemic therapy as the initial treatment of brain metastases, patients who previously responded to systemic therapies had longer survival than patients who had not responded. CONCLUSIONS: The era, pattern, and timing of melanoma brain metastases were found to be strongly associated with survival. Previous responsiveness to systemic therapies did not predict better outcomes overall, but it did correlate with improved survival for patients with brain metastases who were treated with systemic therapies. These factors may be used in guiding patient management and for stratifying patients in clinical trials. Cancer 2011;117:1687-96.

show abstract

Section: Resultsmentioning

confidence: 99%

Prognostic factors for survival in melanoma patients with brain metastases

Davies

Liu

McIntyre

et al. 2010

Cancer

Self Cite

472

358

View full text Add to dashboard Cite

show abstract

“…TMZ, an oral alkylating agent, demonstrated a longer median progression-free survival (1.9 months) when compared with DTIC [1.5 months, P = 0.012, hazard ratio (HR) = 1.37, 95% confidence interval (CI) 1.07-1.75] [10], as well as comparable tolerability, although TMZ's improved progression-free or overall survival was not confirmed in other randomized phase 3 trials such as the European Organization for Research and Treatment of Cancer (EORTC) 18032 trial [11]. PAC administered as a single agent yielded overall response rates of 14-16%, whereas combined therapy with PAC and platinum-based agents had response rates ranging from 20 to 41% [12][13][14][15][16].…”

Section: Introductionmentioning

confidence: 99%

Comparative healthcare costs in patients with metastatic melanoma in the USA

et al. 2015

View full text Add to dashboard Cite

Recent advances have increased treatment options for, and improved clinical outcomes in, metastatic melanoma (mM). Using a large claims database, this retrospective study compared healthcare and adverse event (AE) costs in a US managed care population of mM patients initiating vemurafenib (VEM), ipilimumab (IPI), dacarbazine (DTIC), paclitaxel (PAC), or temozolomide (TMZ) from July 2009 to September 2012. Treatment episodes were identified from the start of study drugs (index date) to a switch to a different study drug, or a gap greater than 45 days (>112 days for IPI). Grade 3/4 adverse events occurring ≥5% from study drug package inserts were selected for this analysis. All-cause costs for treatment episodes and AEs were normalized as monthly costs. Generalized estimating equation models with log link and gamma distribution provided adjusted monthly treatment episode and AE costs. A total of 809 treatment episodes were identified in 541 mM patients, with a mean (SD) age of 57.5 (11.5) years. The total mean (SD) all-cause cost per treatment episode for VEM was $77 687 ($60 329), for IPI was $153 062 ($134 048), for DTIC was $35 243 ($33 641), for TMZ was $42 870 ($41 384), and for PAC was $58 991 ($81 306). The adjusted mean monthly treatment episode cost for VEM was significantly lower than that for IPI and comparable to that for other drugs. VEM had a significantly lower monthly AE cost than IPI, DTIC, and PAC. In combination with safety and efficacy findings, these results may assist clinicians, patients, policy makers, and payers in the treatment of mM.

show abstract

“…Remission rates range from 15 to 25% with a median survival of 7.8 months [16][17][18]. A similar combination to the one we presented of cisplatin, paclitaxel and DTIC was studied in 46 patients with metastatic melanoma [19]. The starting doses of the drugs in this regimen were intravenous cisplatin 20 mg/m 2 on days 1-4, intravenous paclitaxel 120 mg/m 2 on days 1 and 8, and intravenous DTIC 800 mg/m 2 on day 1.…”

Section: Discussionmentioning

confidence: 88%

Phase I dose finding study of carboplatin, paclitaxel, and temozolomide in advanced solid tumors

Movva

Verschraegen²,

Rabinowitz³

et al. 2011

Melanoma Research

View full text Add to dashboard Cite

This phase I study was carried out to evaluate the optimal dose of temozolomide in combination with carboplatin and paclitaxel in patients with advanced solid tumors. Patients with advanced melanoma or small cell lung cancer that could benefit from the combination of carboplatin and paclitaxel were eligible. A standard 3+3 patient cohort dose escalation design was used. Paclitaxel and carboplatin were administered at fixed doses of 175 mg/m on day 1 and an area under the curve of 5, respectively. Temozolomide was administered at a dose of 75 mg/m/day from days 2-6 and subsequent cohorts were dose escalated by 25 mg/m increments. Cycles were repeated every 28 days. The primary objective of this study was to determine the maximum tolerated dose of this combination. Fourteen patients were enrolled and 12 patients were evaluable for toxicity and response (six with melanoma and six with small cell lung cancer). The maximum tolerated dose of temozolomide was 125 mg/m, with fixed doses of carboplatin and paclitaxel. There were no treatment delays nor dose reductions at this level. There were two partial responses and two patients with stable disease in the melanoma group. Four patients had a partial response, and one had stable disease in the small cell lung cancer group. There were sustained responses in three of the four patients with melanoma who achieved a clinical benefit. In conclusion, the combination of carboplatin, paclitaxel, and temozolomide is well tolerated and warrants further study.

show abstract

Phase I/II Study of a Cisplatin-Taxol-Dacarbazine Regimen in Metastatic Melanoma

Abstract: Cisplatin-paclitaxel-dacarbazine regimen is effective in patients with advanced melanoma.

Cited by 18 publications

References 15 publications

Prognostic factors for survival in melanoma patients with brain metastases

Prognostic factors for survival in melanoma patients with brain metastases

Comparative healthcare costs in patients with metastatic melanoma in the USA

Phase I dose finding study of carboplatin, paclitaxel, and temozolomide in advanced solid tumors

Contact Info

Product

Resources

About