A phase 2 clinical trial of nab-Paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma

Evan M Hersh, Steven J. O'Day, Antoni Ribas, Wolfram E. Samlowski, Michael S. Gordon, Deganit E. Shechter, Alicia A. Clawson, Rene Gonzalez

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: nab-Paclitaxel (ABI-007, Abraxane), a 130-nM, albumin-bound (nab) particle form of Cremophor-free paclitaxel, is approved for metastatic breast cancer. In the current study, the efficacy and safety of nab-paclitaxel were evaluated in previously treated and chemotherapy-naive patients with metastatic melanoma (MM). METHODS: Patients with histologically or cytologically confirmed, measurable MM were enrolled. nab-Paclitaxel was administered intravenously weekly for 3 of 4 weeks at a dose of 100 mg/m2 (in previously treated patients) or 150 mg/m2 (in chemotherapy-naive patients). RESULTS: Thirty-seven patients were treated in each cohort. The response rate was 2.7% in the previously treated cohort and 21.6% in the chemotherapy-naive cohort; the response plus stable disease rate was 37.8% and 48.6% in the previously treated and chemotherapy-naive cohorts, respectively. The median progressionfree survival (PFS) was 3.5 months and 4.5 months, and the median survival was 12.1 months and 9.6 months, respectively. The probability of being alive and free of disease progression at 6 months was 27% for the previously treated cohort and 34% for the chemotherapy-naive cohort; the probability of surviving 1 year was 49% and 41%, respectively, for the previously treated and chemotherapy-naive cohorts. Approximately 78% of the previously treated patients and 49% of the chemotherapy-naive patients were treated without dose reduction. Eight (22%) chemotherapy-naive patients discontinued therapy because of toxicities. Drug-related toxicities included grade 3 to 4 (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0]) neuropathy, alopecia, neutropenia, and fatigue. CONCLUSIONS: nab-Paclitaxel was found to be well tolerated and demonstrated activity in both previously treated and chemotherapy-naive patients with MM. The response rate, PFS, and survival compared favorably with current standard dacarbazine therapy and combination therapies for melanoma. nab-Paclitaxel therapy of MM should be investigated further in controlled clinical trials.

Original languageEnglish (US)
Pages (from-to)155-163
Number of pages9
JournalCancer
Volume116
Issue number1
DOIs
StatePublished - Jan 1 2010

Fingerprint

Melanoma
Clinical Trials
Drug Therapy
Survival
Albumin-Bound Paclitaxel
Dacarbazine
National Cancer Institute (U.S.)
Alopecia
Controlled Clinical Trials
Therapeutics
Paclitaxel
Neutropenia
Drug-Related Side Effects and Adverse Reactions
Terminology
Fatigue
Disease Progression
Albumins
Survival Rate
Breast Neoplasms
Safety

Keywords

  • ABI-007 (Abraxane)
  • Melanoma
  • nab-paclitaxel
  • Overall survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Hersh, E. M., O'Day, S. J., Ribas, A., Samlowski, W. E., Gordon, M. S., Shechter, D. E., ... Gonzalez, R. (2010). A phase 2 clinical trial of nab-Paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma. Cancer, 116(1), 155-163. https://doi.org/10.1002/cncr.24720

A phase 2 clinical trial of nab-Paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma. / Hersh, Evan M; O'Day, Steven J.; Ribas, Antoni; Samlowski, Wolfram E.; Gordon, Michael S.; Shechter, Deganit E.; Clawson, Alicia A.; Gonzalez, Rene.

In: Cancer, Vol. 116, No. 1, 01.01.2010, p. 155-163.

Research output: Contribution to journalArticle

Hersh, EM, O'Day, SJ, Ribas, A, Samlowski, WE, Gordon, MS, Shechter, DE, Clawson, AA & Gonzalez, R 2010, 'A phase 2 clinical trial of nab-Paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma', Cancer, vol. 116, no. 1, pp. 155-163. https://doi.org/10.1002/cncr.24720
Hersh, Evan M ; O'Day, Steven J. ; Ribas, Antoni ; Samlowski, Wolfram E. ; Gordon, Michael S. ; Shechter, Deganit E. ; Clawson, Alicia A. ; Gonzalez, Rene. / A phase 2 clinical trial of nab-Paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma. In: Cancer. 2010 ; Vol. 116, No. 1. pp. 155-163.
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abstract = "BACKGROUND: nab-Paclitaxel (ABI-007, Abraxane), a 130-nM, albumin-bound (nab) particle form of Cremophor-free paclitaxel, is approved for metastatic breast cancer. In the current study, the efficacy and safety of nab-paclitaxel were evaluated in previously treated and chemotherapy-naive patients with metastatic melanoma (MM). METHODS: Patients with histologically or cytologically confirmed, measurable MM were enrolled. nab-Paclitaxel was administered intravenously weekly for 3 of 4 weeks at a dose of 100 mg/m2 (in previously treated patients) or 150 mg/m2 (in chemotherapy-naive patients). RESULTS: Thirty-seven patients were treated in each cohort. The response rate was 2.7{\%} in the previously treated cohort and 21.6{\%} in the chemotherapy-naive cohort; the response plus stable disease rate was 37.8{\%} and 48.6{\%} in the previously treated and chemotherapy-naive cohorts, respectively. The median progressionfree survival (PFS) was 3.5 months and 4.5 months, and the median survival was 12.1 months and 9.6 months, respectively. The probability of being alive and free of disease progression at 6 months was 27{\%} for the previously treated cohort and 34{\%} for the chemotherapy-naive cohort; the probability of surviving 1 year was 49{\%} and 41{\%}, respectively, for the previously treated and chemotherapy-naive cohorts. Approximately 78{\%} of the previously treated patients and 49{\%} of the chemotherapy-naive patients were treated without dose reduction. Eight (22{\%}) chemotherapy-naive patients discontinued therapy because of toxicities. Drug-related toxicities included grade 3 to 4 (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0]) neuropathy, alopecia, neutropenia, and fatigue. CONCLUSIONS: nab-Paclitaxel was found to be well tolerated and demonstrated activity in both previously treated and chemotherapy-naive patients with MM. The response rate, PFS, and survival compared favorably with current standard dacarbazine therapy and combination therapies for melanoma. nab-Paclitaxel therapy of MM should be investigated further in controlled clinical trials.",
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AU - Ribas, Antoni

AU - Samlowski, Wolfram E.

AU - Gordon, Michael S.

AU - Shechter, Deganit E.

AU - Clawson, Alicia A.

AU - Gonzalez, Rene

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N2 - BACKGROUND: nab-Paclitaxel (ABI-007, Abraxane), a 130-nM, albumin-bound (nab) particle form of Cremophor-free paclitaxel, is approved for metastatic breast cancer. In the current study, the efficacy and safety of nab-paclitaxel were evaluated in previously treated and chemotherapy-naive patients with metastatic melanoma (MM). METHODS: Patients with histologically or cytologically confirmed, measurable MM were enrolled. nab-Paclitaxel was administered intravenously weekly for 3 of 4 weeks at a dose of 100 mg/m2 (in previously treated patients) or 150 mg/m2 (in chemotherapy-naive patients). RESULTS: Thirty-seven patients were treated in each cohort. The response rate was 2.7% in the previously treated cohort and 21.6% in the chemotherapy-naive cohort; the response plus stable disease rate was 37.8% and 48.6% in the previously treated and chemotherapy-naive cohorts, respectively. The median progressionfree survival (PFS) was 3.5 months and 4.5 months, and the median survival was 12.1 months and 9.6 months, respectively. The probability of being alive and free of disease progression at 6 months was 27% for the previously treated cohort and 34% for the chemotherapy-naive cohort; the probability of surviving 1 year was 49% and 41%, respectively, for the previously treated and chemotherapy-naive cohorts. Approximately 78% of the previously treated patients and 49% of the chemotherapy-naive patients were treated without dose reduction. Eight (22%) chemotherapy-naive patients discontinued therapy because of toxicities. Drug-related toxicities included grade 3 to 4 (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0]) neuropathy, alopecia, neutropenia, and fatigue. CONCLUSIONS: nab-Paclitaxel was found to be well tolerated and demonstrated activity in both previously treated and chemotherapy-naive patients with MM. The response rate, PFS, and survival compared favorably with current standard dacarbazine therapy and combination therapies for melanoma. nab-Paclitaxel therapy of MM should be investigated further in controlled clinical trials.

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