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; Zhang, Hui; Renschler, Markus F.; Socinski, Mark A.

doi:10.1097/jto.0000000000000011

Cited by 33 publications

(26 citation statements)

References 29 publications

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“…This included a study of 281 patients with chemotherapy induced peripheral neuropathy, as captured by the EORTC QLQ-CIPN20 [12]; a study of edema, neuropathy and pain in 1031 patients with lung cancer, as captured by the FACT-Taxane module [22]; as well as a study of nausea in 30 patients with mixed cancer types, as measured by a visual analogue scale ( r = 0.88, p < 0.001) [11]. …”

Section: Resultsmentioning

confidence: 99%

The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review

Atkinson

Ryan

Bennett

et al. 2016

Support Care Cancer

278

177

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Purpose Symptomatic adverse events (AEs) are monitored by clinicians as part of all US-based clinical trials in cancer via the U.S. National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) for the purposes of ensuring patient safety. Recently there has been a charge toward capturing the patient perspective for those AEs amenable to patient self-reporting via patient-reported outcomes (PRO). The aim of this review was to summarize the empirically reported association between analogous CTCAE and PRO ratings. Methods A systematic literature search was conducted using PubMed, EMBASE, Web of Science, and Cochrane databases through July 2015. From a total of 5,658 articles retrieved, 28 studies met inclusion criteria. Results Across studies, patients were of mixed cancer types, including anal, breast, cervical, chronic myeloid leukemia, endometrial, hematological, lung, ovarian, pelvic, pharyngeal, prostate and rectal. Given this mixture, the AEs captured were variable, with many common across studies (e.g., dyspnea, fatigue, nausea, neuropathy, pain, vomiting), as well as several that were disease-specific (e.g., erectile dysfunction, hemoptysis). Overall, the quantified association between CTCAE and PRO ratings fell in the fair to moderate range and had large variation across the majority of studies (n = 21). Conclusions The range of measures used and symptoms captured varied greatly across the reviewed studies. Regardless of concordance metric employed, reported agreement between CTCAE and PRO ratings was moderate at best. To assist with reconciliation and interpretation of these differences toward ultimately improving patient care, an important next step is to explore approaches to integrate PROs with clinician reporting of AEs.

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Section: Resultsmentioning

confidence: 99%

The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review

Atkinson

Ryan

Bennett

et al. 2016

Support Care Cancer

278

177

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“…However, in the phase III trial of nab-paclitaxel plus carboplatin vs. sb-paclitaxel plus carboplatin, patients on nab-paclitaxel arm experienced significantly less grade 3–4 peripheral neuropathy compared with the sb-paclitaxel arm (46). Results based on the FACT-Taxane neuropathy, pain in hands/feet and hearing loss subscales demonstrated significantly less worsening of taxane-related symptoms in the nab-paclitaxel arm compared with the sb-paclitaxel arm, p ≤ 0.002 for all (46, 50). The patient-reported symptom scores were consistent with physician assessments of peripheral neuropathy (50).…”

Section: Safety and Tolerabilitymentioning

confidence: 94%

“…Results based on the FACT-Taxane neuropathy, pain in hands/feet and hearing loss subscales demonstrated significantly less worsening of taxane-related symptoms in the nab-paclitaxel arm compared with the sb-paclitaxel arm, p ≤ 0.002 for all (46, 50). The patient-reported symptom scores were consistent with physician assessments of peripheral neuropathy (50). In addition, patients in the nab-paclitaxel arm who experienced Grade 3–4 peripheral neuropathy experienced a faster median time-to-improvement to Grade 1 (38 vs. 104 days) compared to sb-paclitaxel, respectively.…”

Section: Safety and Tolerabilitymentioning

confidence: 94%

“…In the phase III study, patients in the nab-paclitaxel arm experienced significantly less Grade 3–4 arthralgia and myalgia than patients in the sb-paclitaxel arm (46, 50). In the phase III trial, patients in the nab-paclitaxel arm experienced significantly less Grade 3–4 neutropenia, but more thrombocytopenia and anemia than patients in the sb-based arm (46, 50). …”

Section: Safety and Tolerabilitymentioning

confidence: 99%

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Chemotherapy in Metastatic NSCLC â€“ New Regimens (Pemetrexed, Nab-Paclitaxel)

Blais

Hirsh

2014

Front. Oncol.

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Platinum-based chemotherapy doublets have been the standard approach to first-line therapy for more than a decade. Many randomized trials testing new combinations have not been able to produce significant gains in patient outcomes when these studies have looked at an unselected patient population. The recognition of the biologic importance of histology and molecular features of lung cancer has dramatically impacted on patient care, as can be easily recognized by the advent of targeted therapy for molecularly defined lung cancers. Similarly, for lung cancers without recognized driver mutations, subgroup evaluations of trials-based histology has identified that some chemotherapy regimens offer greater benefit in the squamous cell or the non-squamous cell groups. Two such examples are nab-paclitaxel and pemetrexed. These have shown improved anti-tumor activity and a decreased toxicity profile compared to standard combinations. Preferential activity in histologic divided patient subgroups can allow the clinician to personalize his approach to care. The role of these two agents in the management of NSCLC will be described in this article.

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“…There was a significant treatment effect favoring nab-PC over sb-PC over the entire course of treatment for the total score of all 16 items of the FACT-Taxane questionnaire (Fig. 2, p < 0.001) [56]. The mean change from baseline to final evaluation in the patient-reported FACT-Taxane scale, including a neuropathy subscale (P = 0.001), pain subscale (P = 0.001), and hearing loss subscale (P = 0.002), was significantly improved in the nab-PC arm versus sb-PC arm.…”

Section: Nab-paclitaxel As First-line Therapy For Advanced Nsclcmentioning

confidence: 99%

Is there a role of nab-paclitaxel in the treatment of advanced non-small cell lung cancer? The data suggest yes

Villaruz

Socinski

2016

European Journal of Cancer

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Nab-paclitaxel is a novel therapeutic agent, which was approved in combination with carboplatin in the first-line treatment of advanced non-small cell lung cancer (NSCLC) regardless of histologic subtype in the United States of America by the Food and Drug Administration in 2012 and by the European Commission in 2015. This approval was based on the results of a phase III clinical trial showing superior response rates compared with solvent-based paclitaxel in combination with carboplatin. This review will focus on the early development and clinical data to date supporting the use of nab-paclitaxel in advanced NSCLC. The clinical question central to this review is whether nab-paclitaxel has a place in the current therapeutic landscape of advanced NSCLC.

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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

Abstract: 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.

Cited by 33 publications

References 29 publications

The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review

The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review

Chemotherapy in Metastatic NSCLC â€“ New Regimens (Pemetrexed, Nab-Paclitaxel)

Is there a role of nab-paclitaxel in the treatment of advanced non-small cell lung cancer? The data suggest yes

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