Literature DB >> 29703818

Paclitaxel Plasma Concentration after the First Infusion Predicts Treatment-Limiting Peripheral Neuropathy.

Daniel L Hertz1,2, Kelley M Kidwell2,3, Kiran Vangipuram4, Feng Li5, Manjunath P Pai4, Monika Burness2,6, Jennifer J Griggs2,6, Anne F Schott2,6, Catherine Van Poznak2,6, Daniel F Hayes2,6, Ellen M Lavoie Smith7, N Lynn Henry8.   

Abstract

Purpose: Paclitaxel exposure, specifically the maximum concentration (Cmax) and amount of time the concentration remains above 0.05 μmol/L (Tc>0.05), has been associated with the occurrence of paclitaxel-induced peripheral neuropathy. The objective of this study was to validate the relationship between paclitaxel exposure and peripheral neuropathy.Experimental Design: Patients with breast cancer receiving paclitaxel 80 mg/m2 × 12 weekly doses were enrolled in an observational clinical study (NCT02338115). Paclitaxel plasma concentration was measured at the end of and 16-26 hours after the first infusion to estimate Cmax and Tc>0.05 Patient-reported peripheral neuropathy was collected via CIPN20 at each dose, and an 8-item sensory subscale (CIPN8) was used in the primary analysis to test for an association with Tc>0.05 Secondary analyses were conducted using Cmax as an alternative exposure parameter and testing each parameter with a secondary endpoint of the occurrence of peripheral neuropathy-induced treatment disruption.
Results: In 60 subjects included in the analysis, the increase in CIPN8 during treatment was associated with baseline CIPN8, cumulative dose, and relative dose intensity (P < 0.05), but neither Tc>0.05 (P = 0.27) nor Cmax (P = 0.99). In analyses of the secondary endpoint, cumulative dose (OR = 1.46; 95% confidence interval (CI), 1.18-1.80; P = 0.0008) and Tc>0.05 (OR = 1.79; 95% CI, 1.06-3.01; P = 0.029) or Cmax (OR = 2.74; 95% CI, 1.45-5.20; P = 0.002) were associated with peripheral neuropathy-induced treatment disruption.Conclusions: Paclitaxel exposure is predictive of the occurrence of treatment-limiting peripheral neuropathy in patients receiving weekly paclitaxel for breast cancer. Studies are warranted to determine whether exposure-guided dosing enhances treatment effectiveness and/or prevents peripheral neuropathy in these patients. Clin Cancer Res; 24(15); 3602-10. ©2018 AACR. ©2018 American Association for Cancer Research.

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Year:  2018        PMID： 29703818      PMCID： PMC6386454          DOI： 10.1158/1078-0432.CCR-18-0656

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN： 1078-0432            Impact factor:   12.531


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Journal:  J Natl Cancer Inst       Date:  2018-06-01       Impact factor: 13.506

2.  Comorbidities and Risk of Chemotherapy-Induced Peripheral Neuropathy Among Participants 65 Years or Older in Southwest Oncology Group Clinical Trials.

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Journal:  J Clin Oncol       Date:  2016-06-20       Impact factor: 44.544

3.  SWOG S0221: a phase III trial comparing chemotherapy schedules in high-risk early-stage breast cancer.

Authors:  George T Budd; William E Barlow; Halle C F Moore; Timothy J Hobday; James A Stewart; Claudine Isaacs; Muhammad Salim; Jonathan K Cho; Kristine J Rinn; Kathy S Albain; Helen K Chew; Gary V Burton; Timothy D Moore; Gordan Srkalovic; Bradley A McGregor; Lawrence E Flaherty; Robert B Livingston; Danika L Lew; Julie R Gralow; Gabriel N Hortobagyi
Journal:  J Clin Oncol       Date:  2014-11-24       Impact factor: 44.544

4.  Quantitative effect of gender, age, liver function, and body size on the population pharmacokinetics of Paclitaxel in patients with solid tumors.

Authors:  Markus Joerger; Alwin D R Huitema; Desiree H J G van den Bongard; Jan H M Schellens; Jos H Beijnen
Journal:  Clin Cancer Res       Date:  2006-04-01       Impact factor: 12.531

5.  Prospective evaluation of body surface area as a determinant of paclitaxel pharmacokinetics and pharmacodynamics in women with solid tumors: Cancer and Leukemia Group B Study 9763.

Authors:  Antonius A Miller; Gary L Rosner; Merrill J Egorin; Donna Hollis; Stuart M Lichtman; Mark J Ratain
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Authors:  Lois B Travis; Sophie D Fossa; Howard D Sesso; Robert D Frisina; David N Herrmann; Clair J Beard; Darren R Feldman; Lance C Pagliaro; Robert C Miller; David J Vaughn; Lawrence H Einhorn; Nancy J Cox; M Eileen Dolan
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9.  Taxane-induced peripheral neuropathy and health-related quality of life in postoperative breast cancer patients undergoing adjuvant chemotherapy: N-SAS BC 02, a randomized clinical trial.

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10.  Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials.

Authors:  R Peto; C Davies; J Godwin; R Gray; H C Pan; M Clarke; D Cutter; S Darby; P McGale; C Taylor; Y C Wang; J Bergh; A Di Leo; K Albain; S Swain; M Piccart; K Pritchard
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3.  Genetic variation in Charcot-Marie-Tooth genes contributes to sensitivity to paclitaxel-induced peripheral neuropathy.

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5.  Chromosomal instability sensitizes patient breast tumors to multipolar divisions induced by paclitaxel.

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Review 6.  Optimized Dosing: The Next Step in Precision Medicine in Non-Small-Cell Lung Cancer.

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7.  Paclitaxel exposure-toxicity analysis reveals a pharmacokinetic determinant for dose-limiting neutropenia in East-Asian solid tumor patients: results from two prospective, phase II studies.

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8.  Polyester Nanoparticle Encapsulation Mitigates Paclitaxel-Induced Peripheral Neuropathy.

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9.  Genetic variation in EPHA contributes to sensitivity to paclitaxel-induced peripheral neuropathy.

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Review 10.  Exploring pharmacogenetics of paclitaxel- and docetaxel-induced peripheral neuropathy by evaluating the direct pharmacogenetic-pharmacokinetic and pharmacokinetic-neuropathy relationships.

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