Abstract 4851
Background
Prostate cancer trial design is structured following the Prostate Cancer Clinical Trials Working Group (PCWG) guidelines which focus on harmonization of inclusion criteria and outcome data. The PCWG, however, does not provide clear outlines for reporting of safety data. In fact, there is a perceived lack of widely accepted guidelines for safety reporting.
Methods
A PubMed search of phase II and III clinical trials published until 2015 (included) was conducted using keywords “prostate cancer” and “docetaxel.” Docetaxel-naïve CRPC patients who received 75 mg/m2 docetaxel monotherapy every three weeks were included. To assess quality of toxicity reporting, the Consolidated Standards of Reporting Trials (CONSORT) harms checklist was adapted and each trial scored by two independent reviewers. CONSORT scores as well as PSA and radiological response rates over time were examined with Spearman correlation coefficients. Univariable and multivariable linear regression examined associations between scores and phase II versus III trials, publication year, midpoint of accrual, number of patients, sponsor type, journal impact factor, presence of supplementary data, and geographical region.
Results
From 21 clinical trials including 5,460 patients in docetaxel monotherapy arms, the median CONSORT score was 15.3 (IQR 13.7–16.5) out of 22. Correlation coefficients were not significant for all comparisons of CONSORT scores and response rates versus years of accrual or year of publication. In univariable linear regression, phase III clinical trials were associated with a significantly higher CONSORT score (p = 0.01) as was a journal impact factor greater than 15 (p = 0.02). In exploratory analyses, none of the examined factors were significant in multivariable linear regression.
Conclusions
CONSORT scores and thus toxicity reporting quality in CRPC trials studying docetaxel show need for improvement and should be subject to further discussion. There has been no significant improvement in toxicity reporting quality over time. It remains to be studied if our findings also apply to other agents used for the treatment of CRPC. Legal entity responsible for the study: Sunnybrook Research Institute.
Clinical trial identification
Funding
Joseph and Silvana Melara Cancer Fund.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
2595 - Real-Life Utilization of Genomic testing for invasive Breast Cancer patients in Italy and France reduces Chemotherapy Recommendations
Presenter: Sandro Barni
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2343 - Benefit of adjuvant chemotherapy in hormone receptor-positive, HER2-negative, invasive lobular carcinoma of the breast
Presenter: Alexandre De Nonneville
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2990 - Baseline lymphocyte counts predict distant recurrence in early breast cancer
Presenter: Gun Min Kim
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4532 - A propensity score analysis exploring the impact of the addition of adjuvant chemotherapy (aCT) to hormone therapy (aHT) in a multi-center series of resected luminal early stage pure Invasive Lobular Breast Carcinoma (ILC).
Presenter: Luisa Carbognin
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2344 - Benefit of Adjuvant Systemic Therapies in HR+ HER2- pT1ab Node-Negative Breast Carcinomas
Presenter: Alexandre De Nonneville
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3525 - Anti-proliferative effect of oral metronomic vinorelbine in PAM50 Luminal/HER2-negative early breast cancer (SOLTI-1501 VENTANA): an open-label, randomized, three-arm, multicenter, window-of-opportunity study
Presenter: Aleix Prat
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3908 - Clinicopathologic significance of androgen receptor expression and discordant receptor status during progression in breast cancer
Presenter: Chan Heun Park
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4075 - The outcomes of early breast cancers utilizing the Oncotype Dx Recurrence score (RS) instead of Clinico-pathological (CP) factors for prognostic risk assessment: A Single Institution Experience
Presenter: Adhar Alsayed
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
738 - Circulating tumor cells as a prognostic marker in non metastatic breast cancer patients.
Presenter: Summar Elmorshidy
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3151 - Molecular subtyping of breast cancer by dedicated breast PET
Presenter: Satoshi Sueoka
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract