Patient-reported neuropathy and taxane-associated symptoms in a phase 3 trial of nab-paclitaxel plus carboplatin versus solvent-based paclitaxel plus carboplatin for advanced non-small-cell lung cancer

Vera Hirsh, Isamu Okamoto, Jeremy K. Hon, Ray D. Page, James Orsini, Hiroshi Sakai, Hui Zhang, Markus F. Renschler, Mark A. Socinski

Research output: Contribution to journalArticle

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Abstract

INTRODUCTION: nab-Paclitaxel (nab-P) is approved, in the United States, in combination with carboplatin for the first-line treatment of advanced non-small-cell lung cancer, based on a randomized phase 3 trial of nab-P plus carboplatin (nab-P/C) versus solvent-based paclitaxel plus carboplatin (sb-P/C). This trial revealed a higher overall response rate (33% versus 25%; p = 0.005) and longer, but not statistically significant, overall and progression-free survival for nab-P/C versus sb-P/C. In addition, nab-P/C demonstrated lower rates of grade 3 or higher peripheral neuropathy, myalgia, arthralgia, and neutropenia but higher rates of anemia and thrombocytopenia. This report analyzes patient and physician assessment of symptoms within this trial. METHODS: Patients completed the taxane subscale of the Functional Assessment of Cancer Therapy questionnaire, which focuses on taxane toxicity, including peripheral neuropathy and neurotoxicity. Mean baseline scores and changes from baseline are reported. Physicians also graded the severity of neuropathy at each patient visit using National Cancer Institute Common Toxicity Criteria. RESULTS: Patients receiving nab-P/C reported significantly less worsening of peripheral neuropathy (p < 0.001), pain (p < 0.001), and hearing loss (p = 0.002). Patient-reported edema was similar between the two treatment arms. In agreement with patient-reported symptoms, the results of a per-treatment cycle physician assessment of peripheral neuropathy also favored nab-P/C over sb-P/C (p < 0.001). CONCLUSION: In this trial of patients receiving first-line treatment for advanced non-small-cell lung cancer, nab-P/C was associated with statistically and clinically significant reductions in patient-reported neuropathy, neuropathic pain in the hands and feet, and hearing loss compared with sb-P/C.

Original languageEnglish
Pages (from-to)83-90
Number of pages8
JournalJournal of Thoracic Oncology
Volume9
Issue number1
DOIs
Publication statusPublished - Jan 1 2014
Externally publishedYes

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Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Peripheral Nervous System Diseases
Physicians
Hearing Loss
Therapeutics
Symptom Assessment
National Cancer Institute (U.S.)
130-nm albumin-bound paclitaxel
taxane
Myalgia
Arthralgia
Neuralgia
Neutropenia
Thrombocytopenia
Disease-Free Survival
Foot
Anemia
Edema

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Patient-reported neuropathy and taxane-associated symptoms in a phase 3 trial of nab-paclitaxel plus carboplatin versus solvent-based paclitaxel plus carboplatin for advanced non-small-cell lung cancer. / Hirsh, Vera; Okamoto, Isamu; Hon, Jeremy K.; Page, Ray D.; Orsini, James; Sakai, Hiroshi; Zhang, Hui; Renschler, Markus F.; Socinski, Mark A.

In: Journal of Thoracic Oncology, Vol. 9, No. 1, 01.01.2014, p. 83-90.

Research output: Contribution to journalArticle

Hirsh, Vera ; Okamoto, Isamu ; Hon, Jeremy K. ; Page, Ray D. ; Orsini, James ; Sakai, Hiroshi ; Zhang, Hui ; Renschler, Markus F. ; Socinski, Mark A. / Patient-reported neuropathy and taxane-associated symptoms in a phase 3 trial of nab-paclitaxel plus carboplatin versus solvent-based paclitaxel plus carboplatin for advanced non-small-cell lung cancer. In: Journal of Thoracic Oncology. 2014 ; Vol. 9, No. 1. pp. 83-90.
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AU - Hirsh, Vera

AU - Okamoto, Isamu

AU - Hon, Jeremy K.

AU - Page, Ray D.

AU - Orsini, James

AU - Sakai, Hiroshi

AU - Zhang, Hui

AU - Renschler, Markus F.

AU - Socinski, Mark A.

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AB - INTRODUCTION: nab-Paclitaxel (nab-P) is approved, in the United States, in combination with carboplatin for the first-line treatment of advanced non-small-cell lung cancer, based on a randomized phase 3 trial of nab-P plus carboplatin (nab-P/C) versus solvent-based paclitaxel plus carboplatin (sb-P/C). This trial revealed a higher overall response rate (33% versus 25%; p = 0.005) and longer, but not statistically significant, overall and progression-free survival for nab-P/C versus sb-P/C. In addition, nab-P/C demonstrated lower rates of grade 3 or higher peripheral neuropathy, myalgia, arthralgia, and neutropenia but higher rates of anemia and thrombocytopenia. This report analyzes patient and physician assessment of symptoms within this trial. METHODS: Patients completed the taxane subscale of the Functional Assessment of Cancer Therapy questionnaire, which focuses on taxane toxicity, including peripheral neuropathy and neurotoxicity. Mean baseline scores and changes from baseline are reported. Physicians also graded the severity of neuropathy at each patient visit using National Cancer Institute Common Toxicity Criteria. RESULTS: Patients receiving nab-P/C reported significantly less worsening of peripheral neuropathy (p < 0.001), pain (p < 0.001), and hearing loss (p = 0.002). Patient-reported edema was similar between the two treatment arms. In agreement with patient-reported symptoms, the results of a per-treatment cycle physician assessment of peripheral neuropathy also favored nab-P/C over sb-P/C (p < 0.001). CONCLUSION: In this trial of patients receiving first-line treatment for advanced non-small-cell lung cancer, nab-P/C was associated with statistically and clinically significant reductions in patient-reported neuropathy, neuropathic pain in the hands and feet, and hearing loss compared with sb-P/C.

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