David Lorente1, Praful Ravi2, Niven Mehra2, Carmel Pezaro3, Aurelius Omlin4, Alexa Gilman5, Miguel Miranda5, Pasquale Rescigno2, Michael Kolinsky2, Nuria Porta5, Diletta Bianchini2, Nina Tunariu2, Raquel Perez2, Joaquin Mateo2, Heather Payne6, Leon Terstappen7, Maarten IJzerman7, Emma Hall5, Johann de Bono8. 1. Prostate Cancer Targeted Therapy Group and Drug Development Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton, UK; Medical Oncology Service, Hospital Universitario La Fe, Valencia, Spain. 2. Prostate Cancer Targeted Therapy Group and Drug Development Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton, UK. 3. Monash University Eastern Health Clinical School, Melbourne, Australia. 4. Department of Oncology and Haematology, Kantonsspital St.Gallen, St.Gallen, Switzerland. 5. Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK. 6. Department of Clinical Oncology, University College London Hospital, London, UK. 7. University of Twente, Twente, The Netherlands. 8. Prostate Cancer Targeted Therapy Group and Drug Development Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton, UK. Electronic address: johann.de-bono@icr.ac.uk.
Abstract
BACKGROUND: Evaluation of responses to treatment for metastatic castration-resistant prostate cancer (mCRPC) remains challenging. Consensus criteria based on prostate-specific antigen (PSA) and clinical and radiologic biomarkers are inconsistently utilized. Circulating tumor cell (CTC) counts can inform prognosis and response, but are not routinely used. OBJECTIVE: To evaluate the use of biomarkers and trends in clinical decision-making in current mCRPC treatment. DESIGN, SETTING, AND PARTICIPANTS: A 23-part online questionnaire was completed by physicians treating mCRPC. OUTCOME MEASURES AND STATISTICAL ANALYSIS: Results are presented as the proportion (%) of physicians responding to each of the options. We used χ2 and Fisher's tests to compare differences. RESULTS AND LIMITATIONS: A total of 118 physicians (22.1%) responded. Of these, 69.4% treated ≥50 mCRPC patients/year. More physicians administered four or fewer courses of cabazitaxel (27.9%) than for docetaxel (10.4%), with no significant difference in the number of courses between bone-only disease and Response Evaluation Criteria in Solid Tumours (RECIST)-evaluable disease. Some 74.5% of respondents considered current biomarkers useful for monitoring disease, but only 39.6% used the Prostate Cancer Working Group (PCWG2) criteria in clinical practice. PSA was considered an important biomarker by 55.7%, but only 41.4% discarded changes in PSA before 12 wk, and only 39.4% were able to identify bone-scan progression according to PCWG2. The vast majority of physicians (90.5%) considered clinical progression to be important for switching treatment. The proportion considering biomarkers important was 71.6% for RECIST, 47.4% for bone scans, 23.2% for CTCs, and 21.1% for PSA. Although 53.1% acknowledged that baseline CTC counts are prognostic, only 33.7% would use CTC changes alone to switch treatment in patients with bone-only disease. The main challenges in using CTC counts were access to CTC technology (84.7%), cost (74.5%), and uncertainty over utility as a response indicator (58.2%). CONCLUSIONS: A significant proportion of physicians discontinue treatment for mCRPC before 12 wk, raising concerns about inadequate response assessment. Many physicians find current biomarkers useful, but most rely on symptoms to drive treatment switch decisions, suggesting there is a need for more precise biomarkers. PATIENT SUMMARY: In this report we analyse the results of a questionnaire evaluating tools for clinical decision-making completed by 118 prostate cancer specialists. We found that most physicians favour clinical progression over prostate-specific antigen or imaging, and that criteria established by the Prostate Cancer Working Group are not widely used.
BACKGROUND: Evaluation of responses to treatment for metastatic castration-resistant prostate cancer (mCRPC) remains challenging. Consensus criteria based on prostate-specific antigen (PSA) and clinical and radiologic biomarkers are inconsistently utilized. Circulating tumor cell (CTC) counts can inform prognosis and response, but are not routinely used. OBJECTIVE: To evaluate the use of biomarkers and trends in clinical decision-making in current mCRPC treatment. DESIGN, SETTING, AND PARTICIPANTS: A 23-part online questionnaire was completed by physicians treating mCRPC. OUTCOME MEASURES AND STATISTICAL ANALYSIS: Results are presented as the proportion (%) of physicians responding to each of the options. We used χ2 and Fisher's tests to compare differences. RESULTS AND LIMITATIONS: A total of 118 physicians (22.1%) responded. Of these, 69.4% treated ≥50 mCRPC patients/year. More physicians administered four or fewer courses of cabazitaxel (27.9%) than for docetaxel (10.4%), with no significant difference in the number of courses between bone-only disease and Response Evaluation Criteria in Solid Tumours (RECIST)-evaluable disease. Some 74.5% of respondents considered current biomarkers useful for monitoring disease, but only 39.6% used the Prostate Cancer Working Group (PCWG2) criteria in clinical practice. PSA was considered an important biomarker by 55.7%, but only 41.4% discarded changes in PSA before 12 wk, and only 39.4% were able to identify bone-scan progression according to PCWG2. The vast majority of physicians (90.5%) considered clinical progression to be important for switching treatment. The proportion considering biomarkers important was 71.6% for RECIST, 47.4% for bone scans, 23.2% for CTCs, and 21.1% for PSA. Although 53.1% acknowledged that baseline CTC counts are prognostic, only 33.7% would use CTC changes alone to switch treatment in patients with bone-only disease. The main challenges in using CTC counts were access to CTC technology (84.7%), cost (74.5%), and uncertainty over utility as a response indicator (58.2%). CONCLUSIONS: A significant proportion of physicians discontinue treatment for mCRPC before 12 wk, raising concerns about inadequate response assessment. Many physicians find current biomarkers useful, but most rely on symptoms to drive treatment switch decisions, suggesting there is a need for more precise biomarkers. PATIENT SUMMARY: In this report we analyse the results of a questionnaire evaluating tools for clinical decision-making completed by 118 prostate cancer specialists. We found that most physicians favour clinical progression over prostate-specific antigen or imaging, and that criteria established by the Prostate Cancer Working Group are not widely used.
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