Feasibility and validity of the Patient Neurotoxicity Questionnaire during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC 02
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The aim of the study was to determine the feasibility and validity of a newly developed patient-based instrument—the Patient Neurotoxicity Questionnaire (PNQ)—for grading chemotherapy-induced peripheral neuropathy (CIPN).
Patients and methods
We prospectively collected data from 300 female patients who were treated with taxane chemotherapy for primary breast cancer as part of a national multicenter phase III randomized trial (N-SAS BC 02). We evaluated patient compliance with the PNQ and several validation parameters, including concordance between CIPN grades noted by physicians (National Cancer Institute Common Toxicity Criteria) and patients (PNQ), and the concurrent validity and responsiveness of the PNQ versus the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) utilizing data at pre-treatment and before three, five, and seven treatment cycles.
The questionnaire completion rate was >90% at all assessments. Evaluation by physicians always resulted in lower neuropathy assessment scores compared with those reported directly by patients (weighted kappa coefficients, 0.02–0.06). Both PNQ sensory and motor scores were significantly correlated with the FACT/GOG-Ntx (r = 0.66 and 0.51, respectively). In the repeated measures analysis of variance model, PNQ grades increased considerably as treatment continued, indicating progressively worsening CIPN over time.
The PNQ has an applicable degree of feasibility and validity, useful for the diagnosis of CIPN as well as for clinical treatment decision-making, where the development of CIPN is a potential treatment-limiting consideration. Physicians underreport and underestimate the severity of CIPN symptoms compared with patients, thereby supporting the importance of assessing patient-reported outcomes using the PNQ.
KeywordsNeurotoxicity Patient Neurotoxicity Questionnaire (PNQ) Validation Patient-reported outcomes Peripheral neuropathy
We are grateful to all the patients who participated in this study and all investigators who enrolled patients into the trial. We also thank Yumiko Nomura for data management support and Michiko Kato for assistance with editing the manuscript. This study was mainly supported by the Comprehensive Support Project for Oncology Research (CSPOR) and the Comprehensive Support Project for Health Outcomes Research (CSP-HOR) established by the Public Health Research Foundation (PHRF) in Tokyo, Japan.
- 1.Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JCJM, Kaasa S, Klee M, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw K, Sullivan M, Takeda F, European Organization for Research and Treatment of Cancer Study Group on Quality of Life (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365–376. doi: 10.1093/jnci/85.5.365 CrossRefPubMedGoogle Scholar
- 3.Basch E, Lasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D (2006) Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol 7:903–909. doi: 10.1016/S1470-2045(06)70910-X CrossRefPubMedGoogle Scholar
- 5.Bonomi AE, Cella DF, Hahn EA, Bjordai K, Sperner-Unterweger B, Gangeri L, Bergman B, Willems-Groot J, Hanquet P, Zittoun R (1996) Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual Life Res 5:309–320. doi: 10.1007/BF00433915 CrossRefPubMedGoogle Scholar
- 6.Calhoun EA, Welshman EE, Chang CH, Lurain JR, Fishman DA, Hunt TL, Cella D (2003) Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy. Int J Gynecol Cancer 13:741–748. doi: 10.1111/j.1525-1438.2003.13603.x CrossRefPubMedGoogle Scholar
- 7.Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, Eckberg K, Lioyd S, Purl S, Blendowski C, Goodman M, Barnicle M, Stewart I, McHale M, Bonomi P, Kaplan E, IV TS, Thomas CR Jr, Harris J (1993) The Functional Assessment of Cancer Therapy Scale: development and validation of the general measure. J Clin Oncol 11:570–579PubMedGoogle Scholar
- 9.Fayers PM, Machin D (2007) Scores and measurements: validity, reliability, sensitivity. Quality of life: the assessment, analysis, and interpretation of patient-reported outcomes, 2nd edn. Wiley, Chichester, pp 77–107Google Scholar
- 11.Fumimoto H, Kobayashi K, Chang C-H, Eremenco S, Fujiki Y, Uemura S, Ohashi Y, Kudoh S (2001) Cross-cultural validation of an international questionnaire, the General Measure of the Functional Assessment of Cancer Therapy scale (FACT-G), for Japanese. Qual Life Res 10:701–709. doi: 10.1023/A:1013851216181 CrossRefPubMedGoogle Scholar
- 15.Kurihara M, Shimizu H, Tsuboi K, Kobayashi K, Murakami M, Eguchi K, Shimozuma K (1999) Development of quality of life questionnaire in Japan: quality of life assessment of cancer patients receiving chemotherapy. Psychooncology 8:355–363. doi: 10.1002/(SICI)1099-1611(199907/08)8:4<355::AID-PON401>3.0.CO;2-I CrossRefPubMedGoogle Scholar
- 18.Lipscomb J, Reeve BB, Clauser SB, Abrams JS, Bruner DW, Burke LB, Denicoff AM, Ganz PA, Gondek K, Minasian LM, O’Mara AM, Revicki DA, Rock EP, Rowland JH, Sgambati M, Trimble EL (2007) Patient-reported outcomes assessment in cancer trials: taking stock, moving forward. J Clin Oncol 25:5133–5140. doi: 10.1200/JCO.2007.12.4644 CrossRefPubMedGoogle Scholar
- 19.Mamounas EP, Bryant J, Lembersky BC, Fisher B, Atkins JN, Fehrenbacher L, Raich PC, Yothers G, Soran A, Wolmark N; NSABP Operations and Biostatistical Center, Pittsburgh, PA (2003) Paclitaxel (T) following doxorubicin/cyclophosphamide (AC) as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. Proc Am Soc Clin Oncol 22. Abstract 12.Google Scholar
- 22.Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lantéri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R, EORTC Quality of Life Group (2005) The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer 41:1135–1139. doi: 10.1016/j.ejca.2005.02.012 CrossRefPubMedGoogle Scholar
- 26.Sloan JA, Berk L, Roscoe J, Fisch MJ, Shaw EG, Wyatt G, Morrow GR, Dueck AC (2007) Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-Sponsored Clinical Trials Networks. J Clin Oncol 25:5070–5077. doi: 10.1200/JCO.2007.12.7670 CrossRefPubMedGoogle Scholar