A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma

Lisa A. Kottschade, Vera Jean Suman, Thomas Amatruda, Robert R Mc Williams, Bassam I. Mattar, Daniel A. Nikcevich, Robert Behrens, Tom R. Fitch, Anthony J. Jaslowski, Svetomir Nenad Markovic

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Abstract

Background: There is increasing evidence that paclitaxel and carboplatin are clinically active in the treatment of metastatic melanoma (MM). ABI-007 is an albumin-bound formulation of paclitaxel that has demonstrated single-agent activity against metastatic melanoma. Methods: A parallel phase II trial was conducted in patients with unresectable stage IV melanoma who were either chemotherapy naive (CN) or previously treated (PT). The treatment regimen consisted of ABI-007 (100 mg/m2) and carboplatin area under the curve (AUC2) administered on days 1, 8, and 15 every 28 days. The primary aim of this study was objective response rate (RECIST). Results: Seventy-six patients (41 CN and 35 PT) were enrolled between November 2006 and July 2007. Three patients withdrew consent prior to starting treatment. The median number of treatment cycles was 4. There were 10 (25.6%) responses (1 complete response [CR] and 9 partial responses [PRs]) in the CN cohort (90% CI, 16.7%-42.3%) and 3 (8.8%) responses (3 PRs) in the PT cohort (90% CI, 2.5%-21.3%). Median progression-free survival was 4.5 months in the CN cohort and 4.1 months in the PT cohort. Median overall survival (OS) was 11.1 months in the CN group and 10.9 months in the PT group. Severe toxicities in both groups (Common Terminology Criteria for Adverse Effects v.3.0 ≥grade 3) included neutropenia, thrombocytopenia, neurosensory problems, fatigue, nausea, and vomiting. Conclusions: The weekly combination of ABI-007 and carboplatin appears to be moderately well tolerated, with promising clinical activity as therapy in patients who are chemotherapy naive and with modest antitumor activity in those previously treated.

Original languageEnglish (US)
Pages (from-to)1704-1710
Number of pages7
JournalCancer
Volume117
Issue number8
DOIs
StatePublished - Apr 15 2011

Fingerprint

Carboplatin
Melanoma
Drug Therapy
Therapeutics
Paclitaxel
Neutropenia
Terminology
Thrombocytopenia
Nausea
Disease-Free Survival
Area Under Curve
Vomiting
Fatigue
130-nm albumin-bound paclitaxel
Albumin-Bound Paclitaxel
Survival

Keywords

  • carboplatin
  • chemotherapy
  • metastatic melanoma
  • nab-paclitaxel
  • stage IV
  • unresectable

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma. / Kottschade, Lisa A.; Suman, Vera Jean; Amatruda, Thomas; Mc Williams, Robert R; Mattar, Bassam I.; Nikcevich, Daniel A.; Behrens, Robert; Fitch, Tom R.; Jaslowski, Anthony J.; Markovic, Svetomir Nenad.

In: Cancer, Vol. 117, No. 8, 15.04.2011, p. 1704-1710.

Research output: Contribution to journalArticle

Kottschade, LA, Suman, VJ, Amatruda, T, Mc Williams, RR, Mattar, BI, Nikcevich, DA, Behrens, R, Fitch, TR, Jaslowski, AJ & Markovic, SN 2011, 'A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma', Cancer, vol. 117, no. 8, pp. 1704-1710. https://doi.org/10.1002/cncr.25659
Kottschade, Lisa A. ; Suman, Vera Jean ; Amatruda, Thomas ; Mc Williams, Robert R ; Mattar, Bassam I. ; Nikcevich, Daniel A. ; Behrens, Robert ; Fitch, Tom R. ; Jaslowski, Anthony J. ; Markovic, Svetomir Nenad. / A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma. In: Cancer. 2011 ; Vol. 117, No. 8. pp. 1704-1710.
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abstract = "Background: There is increasing evidence that paclitaxel and carboplatin are clinically active in the treatment of metastatic melanoma (MM). ABI-007 is an albumin-bound formulation of paclitaxel that has demonstrated single-agent activity against metastatic melanoma. Methods: A parallel phase II trial was conducted in patients with unresectable stage IV melanoma who were either chemotherapy naive (CN) or previously treated (PT). The treatment regimen consisted of ABI-007 (100 mg/m2) and carboplatin area under the curve (AUC2) administered on days 1, 8, and 15 every 28 days. The primary aim of this study was objective response rate (RECIST). Results: Seventy-six patients (41 CN and 35 PT) were enrolled between November 2006 and July 2007. Three patients withdrew consent prior to starting treatment. The median number of treatment cycles was 4. There were 10 (25.6{\%}) responses (1 complete response [CR] and 9 partial responses [PRs]) in the CN cohort (90{\%} CI, 16.7{\%}-42.3{\%}) and 3 (8.8{\%}) responses (3 PRs) in the PT cohort (90{\%} CI, 2.5{\%}-21.3{\%}). Median progression-free survival was 4.5 months in the CN cohort and 4.1 months in the PT cohort. Median overall survival (OS) was 11.1 months in the CN group and 10.9 months in the PT group. Severe toxicities in both groups (Common Terminology Criteria for Adverse Effects v.3.0 ≥grade 3) included neutropenia, thrombocytopenia, neurosensory problems, fatigue, nausea, and vomiting. Conclusions: The weekly combination of ABI-007 and carboplatin appears to be moderately well tolerated, with promising clinical activity as therapy in patients who are chemotherapy naive and with modest antitumor activity in those previously treated.",
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AU - Suman, Vera Jean

AU - Amatruda, Thomas

AU - Mc Williams, Robert R

AU - Mattar, Bassam I.

AU - Nikcevich, Daniel A.

AU - Behrens, Robert

AU - Fitch, Tom R.

AU - Jaslowski, Anthony J.

AU - Markovic, Svetomir Nenad

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AB - Background: There is increasing evidence that paclitaxel and carboplatin are clinically active in the treatment of metastatic melanoma (MM). ABI-007 is an albumin-bound formulation of paclitaxel that has demonstrated single-agent activity against metastatic melanoma. Methods: A parallel phase II trial was conducted in patients with unresectable stage IV melanoma who were either chemotherapy naive (CN) or previously treated (PT). The treatment regimen consisted of ABI-007 (100 mg/m2) and carboplatin area under the curve (AUC2) administered on days 1, 8, and 15 every 28 days. The primary aim of this study was objective response rate (RECIST). Results: Seventy-six patients (41 CN and 35 PT) were enrolled between November 2006 and July 2007. Three patients withdrew consent prior to starting treatment. The median number of treatment cycles was 4. There were 10 (25.6%) responses (1 complete response [CR] and 9 partial responses [PRs]) in the CN cohort (90% CI, 16.7%-42.3%) and 3 (8.8%) responses (3 PRs) in the PT cohort (90% CI, 2.5%-21.3%). Median progression-free survival was 4.5 months in the CN cohort and 4.1 months in the PT cohort. Median overall survival (OS) was 11.1 months in the CN group and 10.9 months in the PT group. Severe toxicities in both groups (Common Terminology Criteria for Adverse Effects v.3.0 ≥grade 3) included neutropenia, thrombocytopenia, neurosensory problems, fatigue, nausea, and vomiting. Conclusions: The weekly combination of ABI-007 and carboplatin appears to be moderately well tolerated, with promising clinical activity as therapy in patients who are chemotherapy naive and with modest antitumor activity in those previously treated.

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