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Supportive Care in Cancer

, 17:1483 | Cite as

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

  • Kojiro ShimozumaEmail author
  • Yasuo Ohashi
  • Ayano Takeuchi
  • Toshihiko Aranishi
  • Satoshi Morita
  • Katsumasa Kuroi
  • Shozo Ohsumi
  • Haruhiko Makino
  • Hirohumi Mukai
  • Noriyuki Katsumata
  • Yoshihide Sunada
  • Toru Watanabe
  • Frederick H. Hausheer
Original Article

Abstract

Goals

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.

Main results

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.

Conclusions

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.

Keywords

Neurotoxicity Patient Neurotoxicity Questionnaire (PNQ) Validation Patient-reported outcomes Peripheral neuropathy 

Notes

Acknowledgements

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.

References

  1. 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
  2. 2.
    Ajani JA, Welch SR, Raber MN, Fields WS, Krakoff IH (1990) Comprehensive criteria for assessing therapy-induced toxicity. Cancer Invest 8:147–159. doi: 10.3109/07357909009017560 CrossRefPubMedGoogle Scholar
  3. 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
  4. 4.
    Boehmke MM, Dickerson SS (2005) Symptom, symptom experiences, and symptom distress encountered by women with breast cancer undergoing current treatment modalities. Cancer Nurs 28:382–389. doi: 10.1097/00002820-200509000-00008 CrossRefPubMedGoogle Scholar
  5. 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. 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. 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
  8. 8.
    Cohen J (1968) Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull 70:213–220. doi: 10.1037/h0026256 CrossRefPubMedGoogle Scholar
  9. 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
  10. 10.
    Fromme EK, Eilers KM, Mori M, Hsieh Y-C, Beer TM (2004) How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol 22:3485–3490. doi: 10.1200/JCO.2004.03.025 CrossRefPubMedGoogle Scholar
  11. 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
  12. 12.
    Hausheer FH, Schilsky RL, Bain S, Berghorn EJ, Lieberman F (2006) Diagnosis, management, and evaluation of chemotherapy-induced peripheral neuropathy. Semin Oncol 33:15–49. doi: 10.1053/j.seminoncol.2005.12.010 CrossRefPubMedGoogle Scholar
  13. 13.
    Huang HQ, Brady MF, Cella D, Fleming G (2007) Validation and reduction of FACT/GOG-Ntx subscale for platinum/paclitaxel-induced neurologic symptoms: a Gynecologic Oncology Group study. Int J Gynecol Cancer 17:387–393. doi: 10.1111/j.1525-1438.2007.00794.x CrossRefPubMedGoogle Scholar
  14. 14.
    Hughes RA (2002) Peripheral neuropathy. BMJ 324:466–469. doi: 10.1136/bmj.324.7335.466 CrossRefPubMedGoogle Scholar
  15. 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
  16. 16.
    Kuroi K, Shimozuma K (2004) Neurotoxicity of the taxanes: symptoms and quality of life assessment. Breast Cancer 11:92–99. doi: 10.1007/BF02968010 CrossRefPubMedGoogle Scholar
  17. 17.
    Landis JR, Koch GG (1977) The measurement of observer agreement for categorical data. Biometrics 33:159–174. doi: 10.2307/2529310 CrossRefPubMedGoogle Scholar
  18. 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. 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
  20. 20.
    Ohsumi S, Sunada Y (2004) Techniques for the neurological examination of taxane-induced neuropathy. Breast Cancer 11:86–91. doi: 10.1007/BF02968009 CrossRefPubMedGoogle Scholar
  21. 21.
    Petersen MA, Larsen H, Pedersen L, Sonne N, Groenvold M (2006) Assessing health-related quality of life in palliative care: comparing patient and physician assessments. Eur J Cancer 42:1159–1166. doi: 10.1016/j.ejca.2006.01.032 CrossRefPubMedGoogle Scholar
  22. 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
  23. 23.
    Postma TJ, Heimans JJ (2000) Grading of chemotherapy-induced peripheral neuropathy. Ann Oncol 11:509–513. doi: 10.1023/A:1008345613594 CrossRefPubMedGoogle Scholar
  24. 24.
    Postma TJ, Heimans JJ, Muller MJ, Ossenkoppele GJ, Vermorken JB, Aaronson NK (1998) Pitfalls in grading severity of chemotherapy-induced peripheral neuropathy. Ann Oncol 9:739–744. doi: 10.1023/A:1008344507482 CrossRefPubMedGoogle Scholar
  25. 25.
    Quasthoff S, Hartung HP (2002) Chemotherapy-induced peripheral neuropathy. J Neurol 249:9–17. doi: 10.1007/PL00007853 CrossRefPubMedGoogle Scholar
  26. 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
  27. 27.
    Spearman C (1904) The proof and measurement of association between two things. Am J Psychol 15:72–101. doi: 10.2307/1412159 CrossRefGoogle Scholar
  28. 28.
    Stephens RJ, Hopwood P, Girling DJ, Machin D (1997) Randomized trials with quality of life endpoints: are doctors’ ratings of patients’ physical symptoms interchangeable with patients’ self-ratings? Qual Life Res 6:225–236. doi: 10.1023/A:1026458604826 CrossRefPubMedGoogle Scholar
  29. 29.
    Windebank AJ, Grisold W (2008) Chemotherapy-induced neuropathy. J Peripher Nerv Syst 13:27–46. doi: 10.1111/j.1529-8027.2008.00156.x CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Kojiro Shimozuma
    • 1
    Email author
  • Yasuo Ohashi
    • 2
  • Ayano Takeuchi
    • 2
  • Toshihiko Aranishi
    • 2
  • Satoshi Morita
    • 3
  • Katsumasa Kuroi
    • 4
  • Shozo Ohsumi
    • 5
  • Haruhiko Makino
    • 6
  • Hirohumi Mukai
    • 7
  • Noriyuki Katsumata
    • 8
  • Yoshihide Sunada
    • 9
  • Toru Watanabe
    • 10
  • Frederick H. Hausheer
    • 11
  1. 1.Department of Biomedical Sciences, College of Life SciencesRitsumeikan UniversityKusatsuJapan
  2. 2.Department of Biostatistics, School of Public HealthThe University of TokyoBunkyo-kuJapan
  3. 3.Department of Biostatistics and EpidemiologyYokohama City University Medical CenterYokohamaJapan
  4. 4.Division of Clinical Trials Research, Department of SurgeryTokyo Metropolitan Komagome HospitalBunkyo-kuJapan
  5. 5.Department of Breast OncologyNational Hospital Organization Shikoku Cancer CenterMatsuyamaJapan
  6. 6.Division of Breast OncologyNiigata City General HospitalNiigataJapan
  7. 7.Chemotherapy DivisionNational Cancer Center Hospital EastKashiwaJapan
  8. 8.Breast and Medical Oncology DivisionNational Cancer Center HospitalChuo-kuJapan
  9. 9.Department of NeurologyKawasaki Medical SchoolKurashikiJapan
  10. 10.Hamamatsu Oncology CenterHamamatsuJapan
  11. 11.BioNumerik Pharmaceuticals Inc.San AntonioUSA

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