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Cited by 67Prostate Cancer Treatment and ResearchProstate Cancer Diagnosis and TreatmentBreast Cancer Treatment Studies

Adaptive Therapy for Androgen-Independent Prostate Cancer: A Randomized Selection Trial of Four Regimens

Thall, P. F., Logothetis, C., Pagliaro, L. C., Wen, S., Brown, M. A., Williams, D., Millikan, R. E.·2007·JNCI Journal of the National Cancer Institute
DOI 10.1093/jnci/djm189
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Abstract

BACKGROUND: Physicians typically switch therapies unless clinically relevant thresholds of response are observed, and treatments that produce high-quality responses and that are active in the salvage setting are generally felt to be promising. With the goal of efficiently selecting promising regimens for more advanced trials, we conducted a randomized selection trial of four regimens to identify promising treatments for androgen-independent prostate cancer. METHODS: Patients without prior exposure to cytotoxic therapy were randomly assigned to one of four regimens (i.e., cyclophosphamide, vincristine, and dexamethasone [CVD]; ketoconazole plus doxorubicin alternating with vinblastine plus estramustine [KA/VE]; weekly paclitaxel, estramustine, and carboplatin [TEC]; paclitaxel, estramustine, and etoposide [TEE]). Patients were evaluated every 8 weeks to assess response and adverse events. Patients who responded continued with the same treatment; those who did not were randomly assigned to one of the other three treatments. Response was assessed by considering tumor-specific symptoms, tumor regression, and prostate-specific antigen (PSA) changes. Treatment was continued until two consecutive courses induced a response (i.e., overall success, the major criterion for which was 80% PSA reduction) or until patients were given two different regimens that failed to induce such a response. RESULTS: Median overall survival from registration among all 150 patients was 22 months (95% confidence interval [CI] = 19 to 26 months). Estimated survival at 3 and 5 years, respectively, was 26% (95% CI = 20% to 35%) and 10% (95% CI = 5% to 16%). Overall success was achieved in 35 patients with the initial treatment (i.e., four treated with CVD, seven with KA/VE, 14 with TEC, and 10 with TEE) and in nine more patients with a second-line regimen (i.e., two with CVD, five with KA/VE, and two with TEC). For all 44 (29%, 95% CI = 23% to 37%) patients with overall success, median survival was 30 months (95% CI = 26 to 40 months); for the other 106 patients, it was 19 months (95% CI = 17 to 22 months). TEC produced the greatest number and proportion of successful courses of treatment, and TEC followed by KA/VE was the most promising two-stage strategy. CONCLUSIONS: Some patients responded to particular treatments, and responses to second-line treatments were not rare. We propose that TEC be considered for phase III evaluation.

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Authors
Thall, P. F., Logothetis, C., Pagliaro, L. C., Wen, S., Brown, M. A., Williams, D., & Millikan, R. E.
Affiliations
The University of Texas MD Anderson Cancer Center (US)
ORCID
Venue
JNCI Journal of the National Cancer Institute
Publisher
Oxford University Press (OUP)
Published
2007-10-30
Volume
99
Issue
21
Pages
1613-1622
ISSN
  • 0027-8874 (ISSN-L)
  • 1460-2105
DOI
10.1093/jnci/djm189
OpenAlex
W2144223323
Cited by
67
References
21
Citations by year
2026: 2 · 2025: 1 · 2023: 2 · 2022: 6 · 2021: 3 · 2019: 5 · 2018: 3 · 2017: 7 · 2016: 3 · 2015: 3 · 2014: 4 · 2013: 5 · 2012: 11
FWCI
2.60
Type
journal article
Language
en
Open access
closed
Locations
  • JNCI Journal of the National Cancer Institute (publishedVersion)
  • PubMed (publishedVersion)
  • HighWire Press Open Archive (submittedVersion)
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
Keywords
castration-resistant prostate cancer, adaptive therapy, salvage therapy, paclitaxel, estramustine, carboplatin, etoposide, overall survival, PSA response, second-line therapy
MeSH terms
Aged, Algorithms, Androgens, Antineoplastic Combined Chemotherapy Protocols, Cyclophosphamide, Dexamethasone, Doxorubicin, Drug Administration Schedule, Estramustine, Etoposide, Humans, Ketoconazole, Male, Middle Aged, Prospective Studies, Prostatic Neoplasms, Research Design, Vinblastine, Vincristine, Confidence Intervals, Logistic Models, Survival Analysis, Carboplatin, Treatment Outcome, Paclitaxel, Prostate-Specific Antigen, Disease-Free Survival

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