Impact of cabazitaxel on 2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the TROPIC trial

A Bahl, S Oudard, B Tombal, M Ozgüroglu, S Hansen, I Kocak, G Gravis, J Devin, L Shen, J S de Bono, A O Sartor, TROPIC Investigators, A Bahl, S Oudard, B Tombal, M Ozgüroglu, S Hansen, I Kocak, G Gravis, J Devin, L Shen, J S de Bono, A O Sartor, TROPIC Investigators

Abstract

Background: Cabazitaxel significantly improves overall survival (OS) versus mitoxantrone in patients with metastatic castration-resistant prostate cancer after docetaxel failure. We examined patient survival at 2 years and tumour-related pain with cabazitaxel versus mitoxantrone.

Methods: Updated TROPIC data (cut-off 10 March 2010) were used to compare 2-year survival between treatment groups and assess patient demographics and disease characteristics. Factors prognostic for survival ≥2 years were assessed. Pain and Eastern Cooperative Oncology Group performance status were evaluated in the overall patient population.

Results: Median follow-up was 25.5 months. After 2 years, more patients remained alive following cabazitaxel than mitoxantrone [odds ratio 2.11; 95% confidence interval (CI) 1.33-3.33]. Treatment with cabazitaxel was prognostic for survival ≥2 years. Demographics/baseline characteristics were balanced between treatment arms irrespective of survival. Pain at baseline and pain response were comparable between treatment groups. Average daily pain performance index was lower for cabazitaxel versus mitoxantrone (all cycles; 95% CI -0.27 to -0.01; P = 0.035) and analgesic scores were similar. Grade ≥3 peripheral neuropathies were uncommon and comparable between treatment groups.

Conclusions: Cabazitaxel prolongs OS at 2 years versus mitoxantrone and has low rates of peripheral neuropathy. Palliation benefits of cabazitaxel were comparable to those of mitoxantrone. The study was registered with www.ClinicalTrials.gov (NCT00417079).

Keywords: cabazitaxel; palliative care; prostate cancer; quality of life; symptom relief; treatment response.

Figures

Figure 1.
Figure 1.
Kaplan–Meier estimate of the probability of survival of patients receiving mitoxantrone or cabazitaxel (updated analysis: cut-off 10 March 2010). Originally published in Oudard [5]. With permission from Future Medicine Ltd.
Figure 2.
Figure 2.
Mean AUC for (A) PPI and (B) analgesic score, by treatment cycle. Part A originally published in Oudard [5]. With permission from Future Medicine Ltd.
Figure 3.
Figure 3.
Time to ECOG PS deterioration.

References

    1. Malik Z, di Lorenzo G, Basaran M, et al. Cabazitaxel (Cbz) + prednisone (P) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel (D): interim results from compassionate-use programme (CUP) and early-access programme (EAP). European Society of Medical Oncology Congress; 28 September–2 October, 2012; Vienna, Austria. Poster 931P.
    1. Sanofi. JEVTANA® (cabazitaxel) Injection, Summary of Product Characteristics. Paris, France: 2013. . (4 April 2013, date last accessed)
    1. Sanofi U.S. LLC. JEVTANA® (cabazitaxel) Injection, Prescribing Information. Bridgewater, NJ, USA, 2010. . (4 April 2013, date last accessed)
    1. de Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010;376:1147–1154. .
    1. Oudard S. TROPIC: Phase III trial of cabazitaxel for the treatment of metastatic castration-resistant prostate cancer. Future Oncol. 2011;7:497–506. .
    1. Colloca G, Colloca P. Health-related quality of life assessment in prospective trials of systemic cytotoxic chemotherapy for metastatic castration resistant prostate cancer: which instrument we need? Med Oncol. 2011;28:519–527. .
    1. Deshields T, Potter P, Olsen S, et al. Documenting the symptom experience of cancer patients. J Support Oncol. 2011;9:216–223. .
    1. Lee JJ, Swain SM. Peripheral neuropathy induced by microtubule-stabilizing agents. J Clin Oncol. 2006;24:1633–1642. .
    1. Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975;1:277–299. .
    1. Tannock IF, Osoba D, Stockler MR, et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol. 1996;14:1756–1764.
    1. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011;364:1995–2005. .
    1. Fizazi K, Scher HI, Molina A, et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012;13:983–992. .
    1. Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367:1187–1197. .
    1. Apolone G, Corli O, Caraceni A, et al. Pattern and quality of care of cancer pain management. Results from the Cancer Pain Outcome Research Study Group. Br J Cancer. 2009;100:1566–1574. .
    1. Heidenreich A, Bastian PJ, Bellmunt J, et al. EAU Guidelines on Prostate Cancer. 2012. . (4 April 2013, date last accessed)
    1. Kantoff PW, Halabi S, Conaway M, et al. Hydrocortisone with or without mitoxantrone in men with hormone-refractory prostate cancer: results of the cancer and leukemia group B 9182 study. J Clin Oncol. 1999;17:2506–2513.
    1. National Comprehensive Cancer Network. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Prostate Cancer (Version 2.2013) . (4 April 2013, date last accessed)
    1. Logothetis CJ, Basch E, Molina A, et al. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012;13:1210–1217. .
    1. Sternberg CN, Molina A, North S, et al. Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy. Ann Oncol. 2013;24:1017–1025. .
    1. Parker C, Nilsson S, Heinrich D, et al. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA) J Clin Oncol. 2012;30(Suppl):LBA4512.
    1. Gater A, Abetz-Webb L, Battersby C, et al. Pain in castration-resistant prostate cancer with bone metastases: a qualitative study. Health Qual Life Outcomes. 2011;9:88. .
    1. Sanofi U.S. LLC. NJ, USA: Bridgewater; 2010. TAXOTERE® (docetaxel) Injection Concentrate, Intravenous Infusion (IV) Prescribing Information. . (4 April 2013, date last accessed)
    1. Armstrong AJ, Garrett-Mayer E, de Wit R, et al. Prediction of survival following first-line chemotherapy in men with castration-resistant metastatic prostate cancer. Clin Cancer Res. 2010;16:203–211. .

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