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Erschienen in: Supportive Care in Cancer 12/2012

01.12.2012 | Original Article

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

verfasst von: Kojiro Shimozuma, Yasuo Ohashi, Ayano Takeuchi, Toshihiko Aranishi, Satoshi Morita, Katsumasa Kuroi, Shozo Ohsumi, Haruhiko Makino, Noriyuki Katsumata, Masaru Kuranami, Kimito Suemasu, Toru Watanabe, Frederick H. Hausheer

Erschienen in: Supportive Care in Cancer | Ausgabe 12/2012

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Abstract

Purpose

To elucidate whether adjuvant taxane monotherapy is a feasible and tolerable for postoperative breast cancer patients, we evaluated the severity of chemotherapy-induced peripheral neuropathy (CIPN) and the relative tolerability of regimens by health-related quality of life (HRQOL) assessment in node-positive breast cancer patients treated with taxane-containing regimens.

Methods

We evaluated CIPN and HRQOL in the first 300 patients enrolled in a larger (1,060 total) multicenter phase III trial randomized to one of four adjuvant regimens: (1) anthracycline–cyclophosphamide followed by paclitaxel (ACP), (2) AC followed by docetaxel (ACD), (3) paclitaxel alone (PTX), or (4) docetaxel alone (DTX). CIPN was assessed by the Patient Neurotoxicity Questionnaire (PNQ) and the National Cancer Institute Common Toxicity Criteria, and HRQOL by Functional Assessment of Cancer Therapy-General (FACT-G). CIPN and HRQOL scores were compared between ACP and ACD vs. PTX and DTX, and ACP and PTX vs. ACD and DTX.

Results

PNQ sensory scores were significantly higher in patients treated with taxane monotherapy compared to treatment with AC followed by taxane (P = .003). No significant differences in PNQ sensory scores were observed between the ACP and PTX vs. ACD and DTX regimens (P = .669). Regardless of taxane regimen, PNQ severity scores for CIPN appear to be largely reversible within 1 year of adjuvant treatment. No significant difference in FACT-G scores was observed between any regimens during the study treatments.

Conclusions

Patient-reported CIPN was significantly more severe with single-agent adjuvant taxane compared to AC followed by taxane treatment; however, the HRQOL findings support that single-agent taxane treatment is tolerable.
Literatur
1.
Zurück zum Zitat Ferguson T, Wilcken N, Vagg R, Ghersi D, Nowak AK (2007) Taxanes for adjuvant treatment of early breast cancer. Cochrane Database Syst Rev 4:CD004421PubMed Ferguson T, Wilcken N, Vagg R, Ghersi D, Nowak AK (2007) Taxanes for adjuvant treatment of early breast cancer. Cochrane Database Syst Rev 4:CD004421PubMed
2.
Zurück zum Zitat Sparano JA, Wang M, Martino S et al (2008) Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med 358:1663–1671PubMedCrossRef Sparano JA, Wang M, Martino S et al (2008) Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med 358:1663–1671PubMedCrossRef
3.
Zurück zum Zitat Shan K, Lincoff AM, Young JB (1996) Anthracycline-induced cardiotoxicity. Ann Intern Med 125:47–58PubMed Shan K, Lincoff AM, Young JB (1996) Anthracycline-induced cardiotoxicity. Ann Intern Med 125:47–58PubMed
4.
Zurück zum Zitat Winer EP, Berry DA, Woolf S et al (2004) Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342. J Clin Oncol 22:2061–2068PubMedCrossRef Winer EP, Berry DA, Woolf S et al (2004) Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342. J Clin Oncol 22:2061–2068PubMedCrossRef
6.
Zurück zum Zitat Hilkens PH, ven den Bent MJ (1997) Chemotherapy-induced peripheral neuropathy. J Peripher Nerv Syst 2:350–361PubMed Hilkens PH, ven den Bent MJ (1997) Chemotherapy-induced peripheral neuropathy. J Peripher Nerv Syst 2:350–361PubMed
7.
Zurück zum Zitat Lee JJ, Swain SM (2006) Peripheral neuropathy induced by microtubule-stabilizing agents. J Clin Oncol 24:1633–1642PubMedCrossRef Lee JJ, Swain SM (2006) Peripheral neuropathy induced by microtubule-stabilizing agents. J Clin Oncol 24:1633–1642PubMedCrossRef
8.
Zurück zum Zitat Argyriou AA, Koltzenburg M, Polychronopoulos P, Papapetropoulos S, Kalofonos HP (2008) Peripheral nerve damage associated with administration of taxanes in patients with cancer. Crit Rev Oncol Hematol 66:218–228PubMedCrossRef Argyriou AA, Koltzenburg M, Polychronopoulos P, Papapetropoulos S, Kalofonos HP (2008) Peripheral nerve damage associated with administration of taxanes in patients with cancer. Crit Rev Oncol Hematol 66:218–228PubMedCrossRef
9.
Zurück zum Zitat Wolf S, Barton D, Kottschade L, Grothey A, Loprinzi C (2008) Chemotherapy-induced peripheral neuropathy: prevention and treatment strategies. Eur J Cancer 44:1507–1515PubMedCrossRef Wolf S, Barton D, Kottschade L, Grothey A, Loprinzi C (2008) Chemotherapy-induced peripheral neuropathy: prevention and treatment strategies. Eur J Cancer 44:1507–1515PubMedCrossRef
10.
Zurück zum Zitat Harvey V, Mouridsen H, Semiglazov V et al (2006) Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol 24:4963–4970PubMedCrossRef Harvey V, Mouridsen H, Semiglazov V et al (2006) Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol 24:4963–4970PubMedCrossRef
11.
Zurück zum Zitat Litwin MS, Lubeck DP, Henning JM, Carroll PR (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 159:1988–1992PubMedCrossRef Litwin MS, Lubeck DP, Henning JM, Carroll PR (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 159:1988–1992PubMedCrossRef
12.
Zurück zum Zitat Fromme EK, Eilers KM, Mori M, Hsieh YC, 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 22:3485–3490PubMedCrossRef Fromme EK, Eilers KM, Mori M, Hsieh YC, 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 22:3485–3490PubMedCrossRef
13.
Zurück zum Zitat 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 7:903–909PubMedCrossRef 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 7:903–909PubMedCrossRef
14.
Zurück zum Zitat 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 42:1159–1166PubMedCrossRef 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 42:1159–1166PubMedCrossRef
15.
Zurück zum Zitat Postma TJ, Heimans JJ, Muller MJ, Ossenkoppele GJ, Vermorken JB, Aaronson NK (1998) Pitfalls in grading severity of chemotherapy-induced peripheral neuropathy. Ann Oncol 9:739–744PubMedCrossRef Postma TJ, Heimans JJ, Muller MJ, Ossenkoppele GJ, Vermorken JB, Aaronson NK (1998) Pitfalls in grading severity of chemotherapy-induced peripheral neuropathy. Ann Oncol 9:739–744PubMedCrossRef
16.
Zurück zum Zitat Postma TJ, Heimans JJ (2000) Grading of chemotherapy-induced peripheral neuropathy. Ann Oncol 11:509–513PubMedCrossRef Postma TJ, Heimans JJ (2000) Grading of chemotherapy-induced peripheral neuropathy. Ann Oncol 11:509–513PubMedCrossRef
17.
Zurück zum Zitat Hausheer FH, Schilsky RL, Bain S, Berghorn EJ, Lieberman F (2006) Diagnosis, management, and evaluation of chemotherapy-induced peripheral neuropathy. Semin Oncol 33:15–49PubMedCrossRef Hausheer FH, Schilsky RL, Bain S, Berghorn EJ, Lieberman F (2006) Diagnosis, management, and evaluation of chemotherapy-induced peripheral neuropathy. Semin Oncol 33:15–49PubMedCrossRef
18.
Zurück zum Zitat 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 25:5070–5077PubMedCrossRef 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 25:5070–5077PubMedCrossRef
19.
Zurück zum Zitat Kuroi K, Shimozuma K, Ohashi Y et al (2009) Prospective assessment of chemotherapy-induced peripheral neuropathy due to weekly paclitaxel in patients with advanced or metastatic breast cancer (CSP-HOR 02 study). Support Care Cancer 17:1071–1080PubMedCrossRef Kuroi K, Shimozuma K, Ohashi Y et al (2009) Prospective assessment of chemotherapy-induced peripheral neuropathy due to weekly paclitaxel in patients with advanced or metastatic breast cancer (CSP-HOR 02 study). Support Care Cancer 17:1071–1080PubMedCrossRef
20.
Zurück zum Zitat 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 38:748–754PubMedCrossRef 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 38:748–754PubMedCrossRef
21.
Zurück zum Zitat Shimozuma K, Ohashi Y, Takeuchi A et al (2009) 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. Support Care Cancer 17(12):1483–1491PubMedCrossRef Shimozuma K, Ohashi Y, Takeuchi A et al (2009) 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. Support Care Cancer 17(12):1483–1491PubMedCrossRef
22.
Zurück zum Zitat Cella DF, Tulsky DS, Gray G et al (1993) The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol 11:570–579PubMed Cella DF, Tulsky DS, Gray G et al (1993) The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol 11:570–579PubMed
23.
Zurück zum Zitat Fumimoto H, Kobayashi K, Chang CH et al (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 10:701–709PubMedCrossRef Fumimoto H, Kobayashi K, Chang CH et al (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 10:701–709PubMedCrossRef
24.
Zurück zum Zitat Calhoun EA, Welshman EE, Chang CH et al (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 13:741–748PubMedCrossRef Calhoun EA, Welshman EE, Chang CH et al (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 13:741–748PubMedCrossRef
25.
Zurück zum Zitat 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 17:387–393PubMedCrossRef 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 17:387–393PubMedCrossRef
26.
Zurück zum Zitat Ohsumi S, Sunada Y (2004) Techniques for the neurological examination of taxane-induced neuropathy. Breast Cancer 11:86–91PubMedCrossRef Ohsumi S, Sunada Y (2004) Techniques for the neurological examination of taxane-induced neuropathy. Breast Cancer 11:86–91PubMedCrossRef
27.
Zurück zum Zitat Jones SE, Erban J, Overmoyer B et al (2005) Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol 23:5542–5551PubMedCrossRef Jones SE, Erban J, Overmoyer B et al (2005) Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol 23:5542–5551PubMedCrossRef
Metadaten
Titel
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
verfasst von
Kojiro Shimozuma
Yasuo Ohashi
Ayano Takeuchi
Toshihiko Aranishi
Satoshi Morita
Katsumasa Kuroi
Shozo Ohsumi
Haruhiko Makino
Noriyuki Katsumata
Masaru Kuranami
Kimito Suemasu
Toru Watanabe
Frederick H. Hausheer
Publikationsdatum
01.12.2012
Verlag
Springer-Verlag
Erschienen in
Supportive Care in Cancer / Ausgabe 12/2012
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-012-1492-x

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