Background: Metastatic castration‐resistant prostate cancer (mCRPC) patients have a poor prognosis, and curcumin is known to have antineoplastic properties. On the basis of previous phase I and phase II studies, we investigated whether the association of curcumin with docetaxel could improve prognosis among mCRPC patients.Methods: A total of 50 mCRPC patients (included from June 2014 to July 2016) treated with docetaxel in association with oral curcumin (6 g/d for 7 days every 3 weeks) versus placebo were included in this double‐blind, randomized, phase II study. The primary endpoint was to evaluate the time to progression. Among the secondary endpoints, compliance, overall survival, prostate‐specific antigen (PSA) response, safety, curcumin absorption, and quality of life were investigated. An interim analysis was planned in the modified intention‐to‐treat population with data at 6 months (22 patients per arm).Results: Despite good compliance and a verified absorption of curcumin, no difference was shown for our primary endpoint: progression‐free survival (PFS) between the placebo and curcumin groups was, respectively, 5.3 months versus 3.7 months, p = 0.75. Similarly, no difference was observed for the secondary objectives: PSA response rate (p = 0.88), overall survival (p = 0.50), and quality of life (p = 0.49 and p = 0.47).Conclusion: Even though our previous studies and data in the literature seemed to support an association between curcumin and cancer therapies in order to improve patient outcome and prognosis, the results from this interim analysis clearly showed that adding curcumin to mCRPC patients’ treatment strategies was not efficacious. The study was discontinued on the grounds of futility.
Background: In this study, we investigated whether the association of curcumin and docetaxel among advanced and metastatic breast cancer patients in first or second‐line treatment potentiated the objective response rate.Patients/Methods: A multicentre, randomized, open label, phase‐II study was conducted and included 42 patients from July 2009 to January 2017. The primary endpoint was the objective response rate of the docetaxel‐curcumin combination in comparison with docetaxel alone. The secondary endpoints were the assessment of clinical benefit, overall survival, time‐to‐progression, progression‐free survival, compliance, and safety. An interim analysis was planned to evaluate safety and efficacy.Results: In this interim analysis conducted on 37 patients (19 in the control group vs. 18 in the experimental group), no difference was observed for the objective response rate (p = 0.25, control 73.7% vs. experimental 55.6%). Concerning clinical benefit, overall survival and time‐to‐progression, we also failed to show any difference between the two arms. A slight tendency towards longer progression‐free survival at 12 months after randomization was observed in the curcumin group (65.5% vs. 41.4%) but this difference did not reach significance (p = 0.14).Conclusion: In this study, we showed for the first time that adding oral curcumin for advanced and metastatic breast cancer patients treated with first or second‐line docetaxel was not efficacious, although safe. Consequently, this study was stopped for reasons of futility. Further studies with a larger number of patients, a different curcumin preparation, a longer treatment period and a pharmacokinetic evaluation of curcumin are needed to explore the real efficacy of this compound.
31 March 2020 in Aging Clinical and Experimental Research
Purpose: The proportion of older populations living with cancer is on the increase. Maintaining or improving their quality of life (QoL) has become an important goal in the treatment of cancer and has become an endpoint in clinical trials. Melatonin regulates a wide variety of physiological functions and is involved in the initiation of sleep and the improvement of QoL. With age, the secretion of melatonin decreases and could lead to a deterioration in QoL. Methods: Literature searches were conducted using the PubMed database. The search terms and derivatives of “metastatic cancer”, “older patients”, “quality of life” and “melatonin” were used. Titles and abstracts were screened to identify whether studies were relevant for full-text screening. Results: There is major concern about the symptoms older cancer patients encounter during treatment because they can impact their QoL. Melatonin supplementation presents several benefits for older patients: improvement in survival, decrease in symptoms induced by cancer and cancer treatment, and also improvements in quality of life. Conclusion: It therefore seems appropriate to study the impact of melatonin supplementation during cytotoxic therapy on QoL among elderly patients with metastatic cancer. The use of melatonin as a therapeutic strategy seems particularly suitable for elderly patients, a population known to secrete significantly less melatonin. However, to date, no studies have been conducted in this population.
11 February 2025 in Indian Journal of Gynecologic Oncology
Introduction: Ovarian cancer is the eighth most common cancer among women, accounting for 4.7% of all cancer-related deaths. Objective: In this review, we aimed to describe both established and emerging, prognostic and predictive factors. Results: Some established prognostic factors are clinical, such as age, ECOG, and Body Mass Index. Histological subtype, stage and grade are also prognostic factors, and optimal surgery is one of the main factors. Furthermore, the presence of ascites at diagnosis and cancer Antigen 125 assessment could help to predict patient outcomes. Nevertheless, median survival is less than 5 years. Among the emerging factors, tumor-infiltrating lymphocytes (TILs) have a proven prognostic value, although their predictive value has not been used in routine practice. Inflammatory response marker ratios, i.e., neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios, could have a prognostic value. Circulating tumor DNA is one of the most promising prognostic and predictive factors. Concerning predictive factors, the main one is homologous recombination deficiency, which is a marker for response to PARP inhibitors and platin-based chemotherapy. The KELIM score is also used to predict chemosensitivity. To be validated in routine practice, other predictive factors require further investigation. Conclusion: Despite the poor prognosis in this pathology, some patients are still alive 10 years after diagnosis. A better understanding of this population’s characteristics could help to anticipate patient outcomes and thus adapt their management.