التفاصيل البيبلوغرافية
| العنوان: |
Patient‐reported tolerability of veliparib combined with cisplatin and etoposide for treatment of extensive stage small cell lung cancer: Neurotoxicity and adherence data from the ECOG ACRIN cancer research group E2511 phase II randomized trial |
| المؤلفون: |
Steffen McLouth, Laurie E., Zhao, Fengmin, Owonikoko, Taofeek K., Feliciano, Josephine L., Mohindra, Nisha A., Dahlberg, Suzanne E., Wade, James L., Srkalovic, Gordan, Lash, Bradley W., Leach, Joseph W., Leal, Ticiana A., Aggarwal, Charu, Cella, David, Ramalingam, Suresh S., Wagner, Lynne I. |
| المساهمون: |
National Cancer Institute |
| المصدر: |
Cancer Medicine ; volume 9, issue 20, page 7511-7523 ; ISSN 2045-7634 2045-7634 |
| بيانات النشر: |
Wiley |
| سنة النشر: |
2020 |
| المجموعة: |
Wiley Online Library (Open Access Articles via Crossref) |
| الوصف: |
Objectives The ECOG‐ACRIN Cancer Research Group trial E2511 recently demonstrated a potential benefit for the addition of veliparib to cisplatin‐etoposide (CE) in patients with extensive stage small cell lung cancer (ES‐SCLC) in a phase II randomized controlled trial. Secondary trial endpoints included comparison of the incidence and severity of neurotoxicity, hypothesized to be lower in the veliparib arm, and tolerability of the addition of veliparib to CE. Physician‐rated and patient‐reported neurotoxicity was also compared. Materials and Methods Patients randomized to veliparib plus CE (n = 64) or placebo plus CE (n = 64) completed the 11‐item Functional Assessment of Cancer Therapy Gynecologic Oncology Group Neurotoxicity (questionnaire pre‐treatment, end of cycle 4 [ie 3 months after randomization] and 3 months post‐treatment [ie 6‐months]). Adherence analysis was based on treatment forms. Results and Conclusion No significant differences in mean or magnitude of change in neurotoxicity scores were observed between treatment arms at any time point. However, patients in the placebo arm reported worsening neurotoxicity from baseline to 3‐months (M difference = −1.5, P = .045), compared to stable neurotoxicity in the veliparib arm (M difference = −0.2, P = .778). Weakness was the most common treatment‐emergent (>50%) and moderate to severe (>16%) symptom reported, but did not differ between treatment arms. The proportion of adherence to oral therapy in the overall sample was 75%. Three percent of patients reported clinically significant neurotoxicity that was not captured by physician assessment. Neurotoxicity scores were not different between treatment arms. The addition of veliparib to CE appeared tolerable, though weakness should be monitored. ClinicalTrials.gov Identifier NCT01642251. |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.1002/cam4.3416 |
| الإتاحة: |
https://doi.org/10.1002/cam4.3416Test |
| حقوق: |
http://creativecommons.org/licenses/by/4.0Test/ |
| رقم الانضمام: |
edsbas.D988C112 |
| قاعدة البيانات: |
BASE |
