S-E Al-Batran1, W Hozaeel2, F K Tauchert3, R-D Hofheinz4, A Hinke5, C Windemuth-Kieselbach6, A Hübner7, M Burmester8, M Koenigsmann9, J Wiegand10, G Zur Hausen2, B Linsse11, R Kuhl12, C Pauligk2. 1. Institute of Clinical Cancer Research, Krankenhaus Nordwest, University Cancer Center, Frankfurt. Electronic address: albatran@aol.com. 2. Institute of Clinical Cancer Research, Krankenhaus Nordwest, University Cancer Center, Frankfurt. 3. Clinic for Oncology and Hematology, Krankenhaus Nordwest, Frankfurt. 4. Interdisciplinary Tumour Centre, University Hospital Mannheim, Mannheim. 5. WiSP Research Institute, Langenfeld. 6. Alcedis GmbH, Gießen. 7. Oncology and Urology, Wissenschaftskontor Nord GmbH & Co KG, Rostock. 8. Clinic for Urology, Vinzenzkrankenhaus Hannover, Hannover. 9. Oncology and Hematology, Onkologisches Ambulanzzentrum, Hannover. 10. Oncology and Hematology, Onkologische Praxis, Moers. 11. Clinical Study Unit. 12. Medical Oncology, Sanofi-Aventis Deutschland GmbH, Berlin, Germany.
Abstract
BACKGROUND: Docetaxel is a widely used cytotoxic agent. This study evaluates the impact of docetaxel toxicities on patient's health-related quality of life (QoL). PATIENTS AND METHODS: We conducted a multicenter, prospective, non-interventional trial, in which the QoL was assessed using the EORTC QLQ-C30 questionnaires at baseline and every 4 weeks up to 40 weeks in patients receiving a docetaxel-based chemotherapy for metastatic disease. Treatment-related adverse events were correlated with the corresponding QoL scores. Uni- and multivariate analyses were applied. RESULTS: From January 2008 to June 2011, a total of 2659 patients were included. The majority of patients (48.1%) had prostate cancer, followed by breast (17.1%) and non-small-cell-lung cancer (15.8%). Patients received a median of 5 docetaxel cycles with the median dose of 75 mg/m(2). The presence of grade 3/4 diarrhea showed the strongest effect on global health status/QoL average scores (50.91 versus 33.06), followed by vomiting (50.91 versus 35.17), dyspnea (50.94 versus 35.81), mucositis/stomatitis (50.88 versus 36.41), nausea (50.91 versus 36.68), infection (50.90 versus 37.14), fatigue (50.90 versus 43.82) and anemia (50.91 versus 41.03), P < 0.05 for all comparisons. Grade 3/4 leukopenia/neutropenia, alopecia, constipation, neurotoxicity and nail disorders had no significant impact on the global health status/QoL or other items. CONCLUSION: In this large non-interventional trial, docetaxel-associated grade 3 or 4 toxicities were shown to have a strong detrimental effect on patient's QoL. Notably, diarrhea and vomiting had the strongest negative impact on QoL measures. This has to be kept in mind while making therapeutic decisions and providing optimized supportive treatment measures. CLINICAL TRIALS NUMBER: This study was registered at Deutsches Krebsstudienregister (DKSR, primary registry in the WHO Registry Network) with the ID 527.
BACKGROUND: Docetaxel is a widely used cytotoxic agent. This study evaluates the impact of docetaxel toxicities on patient's health-related quality of life (QoL). PATIENTS AND METHODS: We conducted a multicenter, prospective, non-interventional trial, in which the QoL was assessed using the EORTC QLQ-C30 questionnaires at baseline and every 4 weeks up to 40 weeks in patients receiving a docetaxel-based chemotherapy for metastatic disease. Treatment-related adverse events were correlated with the corresponding QoL scores. Uni- and multivariate analyses were applied. RESULTS: From January 2008 to June 2011, a total of 2659 patients were included. The majority of patients (48.1%) had prostate cancer, followed by breast (17.1%) and non-small-cell-lung cancer (15.8%). Patients received a median of 5 docetaxel cycles with the median dose of 75 mg/m(2). The presence of grade 3/4 diarrhea showed the strongest effect on global health status/QoL average scores (50.91 versus 33.06), followed by vomiting (50.91 versus 35.17), dyspnea (50.94 versus 35.81), mucositis/stomatitis (50.88 versus 36.41), nausea (50.91 versus 36.68), infection (50.90 versus 37.14), fatigue (50.90 versus 43.82) and anemia (50.91 versus 41.03), P < 0.05 for all comparisons. Grade 3/4 leukopenia/neutropenia, alopecia, constipation, neurotoxicity and nail disorders had no significant impact on the global health status/QoL or other items. CONCLUSION: In this large non-interventional trial, docetaxel-associated grade 3 or 4 toxicities were shown to have a strong detrimental effect on patient's QoL. Notably, diarrhea and vomiting had the strongest negative impact on QoL measures. This has to be kept in mind while making therapeutic decisions and providing optimized supportive treatment measures. CLINICAL TRIALS NUMBER: This study was registered at Deutsches Krebsstudienregister (DKSR, primary registry in the WHO Registry Network) with the ID 527.
Authors: Beate Rau; Andreas Brandl; Pompiliu Piso; Jörg Pelz; Peter Busch; Cedric Demtröder; Silke Schüle; Hans-Jürgen Schlitt; Marc Roitman; Jürgen Tepel; Udo Sulkowski; Faik Uzunoglu; Michael Hünerbein; Rüdiger Hörbelt; Michael Ströhlein; Stefan Beckert; Ingmar Königsrainer; Alfred Königsrainer Journal: Gastric Cancer Date: 2019-06-21 Impact factor: 7.370
Authors: Mark de Mol; Sabine Visser; Joachim Aerts; Paul Lodder; Nico van Walree; Huub Belderbos; Brenda den Oudsten Journal: BMC Cancer Date: 2020-05-18 Impact factor: 4.430
Authors: S-E Al-Batran; E Van Cutsem; S C Oh; G Bodoky; Y Shimada; S Hironaka; N Sugimoto; O N Lipatov; T-Y Kim; D Cunningham; P Rougier; K Muro; A M Liepa; K Chandrawansa; M Emig; A Ohtsu; H Wilke Journal: Ann Oncol Date: 2016-01-07 Impact factor: 32.976