Abstract | BACKGROUND: PATIENTS AND METHODS: RESULTS: Of 125 patients enrolled, 52 (42%) experienced ≥ 50% PSA decline on induction D+P and were randomized to GM-CSF (n = 27) or Obs (n = 25). The median time to PD was 3.3 months (95% confidence interval [CI], 2.4-3.5) and 1.5 months (95% CI, 1.5-2.4) during the initial course of GM-CSF and Obs, respectively. Twelve of 26 (46%) patients responded to a second course of D+P. Eleven randomized patients (21%) experienced PD during chemotherapy, precluding accurate assessment of TTCR. The remaining 41 randomized patients discontinued study for lack of PSA response to chemotherapy (n = 8), patient choice to not restart chemotherapy with PSA PD (n = 13), toxicity (n = 7), or study withdrawal (n = 13). CONCLUSION: Conducting a prospective study in mCRPC with maintenance immunotherapy within the framework of intermittent chemotherapy was feasible. The use of PSA instead of radiographic end points limited the number of evaluable patients. This study provides important insight into designing contemporary intermittent chemotherapy trials with maintenance immunotherapy in patients with advanced prostate cancer.
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Authors | Rahul R Aggarwal, Tomasz M Beer, Vivian K Weinberg, Celestia Higano, Mary-Ellen Taplin, Charles J Ryan, Amy M Lin, Joshi Alumkal, Julie N Graff, Luke T Nordquist, Isheen Herrera, Eric J Small |
Journal | Clinical genitourinary cancer
(Clin Genitourin Cancer)
Vol. 13
Issue 3
Pg. e191-8
(Jun 2015)
ISSN: 1938-0682 [Electronic] United States |
PMID | 25557266
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S.)
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Copyright | Copyright © 2015 Elsevier Inc. All rights reserved. |
Chemical References |
- Antineoplastic Agents
- Taxoids
- Docetaxel
- Granulocyte-Macrophage Colony-Stimulating Factor
- Prostate-Specific Antigen
- Prednisone
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Topics |
- Aged
- Aged, 80 and over
- Antineoplastic Agents
(administration & dosage, therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, therapeutic use)
- Docetaxel
- Drug Administration Schedule
- Granulocyte-Macrophage Colony-Stimulating Factor
(administration & dosage, therapeutic use)
- Humans
- Maintenance Chemotherapy
- Male
- Middle Aged
- Neoplasm Metastasis
- Prednisone
(administration & dosage, therapeutic use)
- Prospective Studies
- Prostate-Specific Antigen
(metabolism)
- Prostatic Neoplasms, Castration-Resistant
(drug therapy, metabolism, pathology)
- Survival Analysis
- Taxoids
(administration & dosage, therapeutic use)
- Treatment Outcome
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