Top

Published in:

01-08-2009 | Original Article

Prospective assessment of chemotherapy-induced peripheral neuropathy due to weekly paclitaxel in patients with advanced or metastatic breast cancer (CSP-HOR 02 study)

Authors: Katsumasa Kuroi, Kojiro Shimozuma, Yasuo Ohashi, Kazufumi Hisamatsu, Norikazu Masuda, Ayano Takeuchi, Toshihiko Aranishi, Satoshi Morita, Shozo Ohsumi, Frederick H. Hausheer

Published in: Supportive Care in Cancer | Issue 8/2009

Abstract

Goals of work

The aim of this study was to prospectively evaluate chemotherapy-induced peripheral neuropathy (CIPN) using a patient-based instrument, the Patient Neurotoxicity Questionnaire (PNQ) and a physician-based instrument, the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) in patients with advanced or metastatic breast cancer who were treated with weekly paclitaxel.

Materials and methods

CIPN symptoms were prospectively assessed in 35 patients using the PNQ, NCI-CTC, and the Functional Assessment of Cancer Therapy (FACT)-Taxane including neurotoxicity component (Ntx) at the baseline, and 8 and 16 weeks after starting chemotherapy.

Results

For sensory neuropathy symptoms, the reported incidence of CIPN was significantly increased during active treatment in terms of both the PNQ and NCI-CTC assessments. In contrast, there was a notable increase of patient motor neuropathy symptoms that were elucidated only by the PNQ. The PNQ grades of CIPN were widely distributed in the patient population as compared with the NCI-CTC grades for both sensory and motor neuropathy. The sensory PNQ grade was correlated with sensory NCI-CTC grade (r = 0.58) and Ntx (r = 0.51), and the motor PNQ grade was correlated with Ntx (r = 0.57).

Conclusions

The PNQ appears to be more sensitive and responsive than the NCI-CTC for CIPN; the PNQ appears to have diagnostic validity for evaluating CIPN in patients who are receiving neurotoxic chemotherapy.

Basch E, Iasonos A, McDonough T et al (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 PubMedCrossRef

Basch E, Artz D, Dulko D et al (2005) Patient online self-reporting of toxicity symptoms during chemotherapy. J Clin Oncol 23:3552–3561 doi:10.1200/JCO.2005.04.275 PubMedCrossRef

Burckhardt CS, Jones KD (2005) Effects of chronic widespread pain on the health status and quality of life of women after breast cancer surgery. Health Qual Life Outcomes 3:30 doi:10.1186/1477-7525-3-30 PubMedCrossRef

Cavaletti G, Bogliun G, Marzorati L et al (2003) Grading of chemotherapy-induced peripheral neurotoxicity using the total neuropathy scale. Neurology 61:1297–1300PubMed

Cavaletti G, Jann S, Pace A et al (2006) Multi-center assessment of the total neuropathy score for chemotherapy-induced peripheral neurotoxicity. J Peripher Nerv Syst 11:135–141 doi:10.1111/j.1085-9489.2006.00078.x PubMedCrossRef

Cella D, Peterman A, Hudgens S et al (2003) Measuring the side effects of taxane therapy in oncology: the functional assessment of cancer therapy-taxane (FACT-taxane). Cancer 98:822–831 doi:10.1002/cncr.11578 PubMedCrossRef

Eniu A, Palmieri FM, Perez EA (2005) Weekly administration of docetaxel and paclitaxel in metastatic or advanced breast cancer. Oncologist 10:665–685 doi:10.1634/theoncologist.10-9-665 PubMedCrossRef

Fountzilas G, Dafni U, Dimopoulos MA et al (2008) A randomized phase III study comparing three anthracycline-free taxane-based regimens, as first line chemotherapy, in metastatic breast cancer: a Hellenic Cooperative Oncology Group study. Breast Cancer Res Treat doi:10.1007/s10549-008-0047-9, May 16

Fromme EK, Eilers KM, Mori M et al (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 PubMedCrossRef

10.

Garcia SF, Cella D, Clauser SB et al (2007) Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. J Clin Oncol 25:5106–5112 doi:10.1200/JCO.2007.12.2341 PubMedCrossRef

11.

Green MC, Buzdar AU, Smith T et al (2005) Weekly paclitaxel improves pathologic complete remission in operable breast cancer when compared with paclitaxel once every 3 weeks. J Clin Oncol 23:5983–5992 doi:10.1200/JCO.2005.06.232 PubMedCrossRef

12.

Gulluoglu BM, Cingi A, Cakir T et al (2006) Factors related to post-treatment chronic pain in breast cancer survivors: the interference of pain with life functions. Int J Fertil Womens Med 51:75–82PubMed

13.

Hausheer FH, Schilsky RL, Bain S et al (2006) Diagnosis, management, and evaluation of chemotherapy-induced peripheral neuropathy. Semin Oncol 33:15–49 doi:10.1053/j.seminoncol.2005.12.010 PubMedCrossRef

14.

Kudel I, Edwards RR, Kozachik S et al (2007) Predictors and consequences of multiple persistent postmastectomy pains. J Pain Symptom Manage 34:619–627 doi:10.1016/j.jpainsymman.2007.01.013 PubMedCrossRef

15.

Kuroi K, Shimozuma K (2004) Neurotoxicity of taxanes: symptoms and quality of life assessment. Breast Cancer 11:92–99 doi:10.1007/BF02968010 PubMedCrossRef

16.

Kuroi K, Shimozuma K, Ohashi Y et al (2008) A questionnaire survey of physicians’ perspectives regarding the assessment of chemotherapy-induced peripheral neuropathy in patients with breast cancer. Jpn J Clin Oncol 38:748–754 doi:10.1093/jjco/hyn100 PubMedCrossRef

17.

Lipton RB, Apfel SC, Dutcher JP et al (1989) Taxol produces a predominantly sensory neuropathy. Neurology 39:368–373PubMed

18.

Litwin MS, Lubeck DP, Henning JM et al (1998) Differences in urologist and patient assessments of health related quality of life in men with prostate cancer: results of the CaPSURE database. J Urol 159:1988–1992 doi:10.1016/S0022-5347(01)63222-1 PubMedCrossRef

19.

Makino H (2004) Treatment and care of neurotoxicity from taxane anticancer agents. Breast Cancer 11:100–104 doi:10.1007/BF02968011 PubMedCrossRef

20.

Ohsumi S, Sunada Y (2004) Techniques for the neurological examination of taxane-induced neuropathy. Breast Cancer 11:86–91 doi:10.1007/BF02968009 PubMedCrossRef

21.

Perez EA, Vogel CL, Irwin DH et al (2001) Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol 19:4216–4223PubMed

22.

Postma TJ, Heimans JJ, Muller MJ et al (1998) Pitfalls in grading severity of chemotherapy-induced peripheral neuropathy. Ann Oncol 9:739–744 doi:10.1023/A:1008344507482 PubMedCrossRef

23.

Rowinsky EK, Chaudhry V, Cornblath DR et al (1993) Neurotoxicity of taxol. J Natl Cancer Inst Monogr 15:107–115PubMed

24.

Seidman AD (2005) “Will weekly work”? Seems to be so. J Clin Oncol 23:5873–5874 doi:10.1200/JCO.2005.05.031 PubMedCrossRef

25.

Seidman AD, Hudis CA, Albanel J et al (1998) Dose-dense therapy with weekly 1-hour paclitaxel infusions in the treatment of metastatic breast cancer. J Clin Oncol 16:3353–3361PubMed

26.

Seidman AD, Berry D, Cirrincione C et al (2008) Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol 26:1642–1649 doi:10.1200/JCO.2007.11.6699 PubMedCrossRef

27.

Shimozuma K, Ohashi Y, Takeuchi A et al (2004) Validation of the Patient Neurotoxicity Questionnaire (PNQ) during taxane chemotherapy in a phase III randomized trial of breast cancer: N-SAS BC 02. 27th SABCS (#6037)

28.

Shimozuma K, Ohashi Y, Takeuchi A et al (2006) Assessment and quantification of taxane-induced neurotoxicity in a phase III randomized trial of patients with breast cancer (AC followed by PAC/DOC vs. PAC/DOC alone): N-SAS BC 02. 42th ASCO (#8523), Altanta

29.

Sloan JA, Berk L, Roscoe J et al (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 PubMedCrossRef

30.

Sparano JA, Wang M, Martino S et al (2008) Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med 358:1663–1671 doi:10.1056/NEJMoa0707056 PubMedCrossRef

31.

Stephens RJ, Hopwood P, Girling DJ et al (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 PubMedCrossRef

32.

Velikova G, Wright P, Smith AB et al (2001) Self-reported quality of life of individual cancer patients: concordance of results with disease course and medical records. J Clin Oncol 19:2064–2073PubMed

33.

Visovsky C, Collins M, Abbott L et al (2007) Putting evidence into practice: evidence-based interventions for chemotherapy-induced peripheral neuropathy. Clin J Oncol Nurs 11:901–913 doi:10.1188/07.CJON.901-913 PubMedCrossRef

34.

Vogelzang NJ, Breitbart W, Cella D et al (1997) Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. The Fatigue Coalition. Semin Hematol 34:4–12PubMed

35.

Wolf S, Barton D, Kottschade L et al (2008) Chemotherapy-induced peripheral neuropathy: prevention and treatment strategies. Eur J Cancer 44:1507–1515 doi:10.1016/j.ejca.2008.04.018 PubMedCrossRef

Title: Prospective assessment of chemotherapy-induced peripheral neuropathy due to weekly paclitaxel in patients with advanced or metastatic breast cancer (CSP-HOR 02 study)
Authors: Katsumasa Kuroi
Kojiro Shimozuma
Yasuo Ohashi
Kazufumi Hisamatsu
Norikazu Masuda
Ayano Takeuchi
Toshihiko Aranishi
Satoshi Morita
Shozo Ohsumi
Frederick H. Hausheer
Publication date: 01-08-2009
Publisher: Springer-Verlag
Published in: Supportive Care in Cancer / Issue 8/2009
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-008-0550-x

Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras

Prof. Fabrice Barlesi

Developed by: Springer Medicine

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Goals of work

Materials and methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 8/2009

Patient and practice impact of capecitabine compared to taxanes in first-/second-line chemotherapy for metastatic breast cancer

Patients with cancer and e-mail: implications for clinical communication

What are the unmet supportive care needs of people with cancer? A systematic review

Changes in employment and household income during the 24 months following a cancer diagnosis

Aprepitant as salvage antiemetic therapy in breast cancer patients receiving doxorubicin and cyclophosphamide

Depression in lung cancer patients: is the HADS an effective screening tool?

Keynote webinar | Spotlight on antibody–drug conjugates in cancer