ABSTRACT
Background: Chemotherapy-induced peripheral neuropathy (CIPN) can adversely affect completion of systemic anticancer treatment and cause long-term morbidity. To date, its physiopathology remains unclear, and treatments are rare and poorly performed. Auricular acupuncture has already offered interesting results in several symptoms. Objective: This study (AACIPN2020) assessed the efficacy of auriculotherapy in CIPN. Design: We used patients' systematically collected data of 2014-2016 in a medical oncology practice. The treatment was made according to guidelines of the interuniversity diploma and the cartography of the World Health Organization. Pain assessment according to the Common Terminology Criteria for Adverse Event scale was orally collected. Results: Seventy-three cancer patients were treated for CIPN. They had finished chemotherapy 24 weeks prior on average. They received on average 23 punctures at each appointment. Sixty-five percent of patients met satisfaction, with 31% with a real impact on their daily life. Efficacy appeared after one or two treatments for 96% of cases. Some patients continued treatment to maximize benefits. Conclusions: Auricular acupuncture is a safe and inexpensive method of CIPN treatment. It may be applied earlier in chemotherapy administration, and in a large variety of other symptoms. Clinical trial registration number: COS RGDS 2019 09 001.
ABSTRACT
PURPOSE: Mitoxantrone-corticosteroid is currently the standard palliative treatment in hormone-refractory prostate cancer (HRPC) patients. Recent clinical trials documented the high activity of the docetaxel-estramustine combination. We conducted a randomized phase II study to evaluate prostate-specific antigen (PSA) response (primary end point) and safety of two docetaxel-estramustine-prednisone (DEP) regimens and mitoxantrone-prednisone (MP). PATIENTS AND METHODS: One hundred thirty metastatic HRPC patients were randomly assigned to receive docetaxel (70 mg/m2 on day 2 or 35 mg/m2 on days 2 and 9 of each 21-day cycle) and estramustine (280 mg p.o. tid on days 1 through 5 and 8 through 12) or mitoxantrone 12 mg/m2 every 3 weeks; all patients received prednisone (10 mg daily). RESULTS: One hundred twenty-seven patients were assessable for PSA response and safety. A > or = 50% PSA decline was found in a greater percentage of patients in the docetaxel arms (67% and 63%) compared with MP (18%; P = .0001). Median time to PSA progression was five times longer with DEP than with MP (8.8 and 9.3 v 1.7 months, respectively; P = .000001). Overall survival was better in the docetaxel arms (18.6 and 18.4 months) compared with the MP arm (13.4 months), but not significantly so (P = .3). Crossover rates differed significantly among treatment arms (16%, 10%, and 48% in arms A, B, and C, respectively; P = .00001). Treatment-related toxicities were mild and mainly hematologic. CONCLUSION: The results of this randomized phase II study showed significantly higher PSA decline < or = 50% and longer times to progression in HRPC patients receiving DEP-based chemotherapy than MP, and that DEP could be proposed in this setting.
Subject(s)
Adenocarcinoma/drug therapy , Adenocarcinoma/secondary , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Biomarkers, Tumor/analysis , Neoplasms, Hormone-Dependent/drug therapy , Prostate-Specific Antigen/analysis , Prostatic Neoplasms/drug therapy , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Disease Progression , Docetaxel , Dose-Response Relationship, Drug , Drug Administration Schedule , Estramustine/administration & dosage , Estramustine/adverse effects , Follow-Up Studies , Humans , Male , Maximum Tolerated Dose , Middle Aged , Mitoxantrone/administration & dosage , Mitoxantrone/adverse effects , Multivariate Analysis , Neoplasm Invasiveness/pathology , Neoplasm Staging , Neoplasms, Hormone-Dependent/diagnosis , Neoplasms, Hormone-Dependent/mortality , Prednisone/administration & dosage , Prednisone/adverse effects , Proportional Hazards Models , Prostatic Neoplasms/diagnosis , Prostatic Neoplasms/mortality , Risk Factors , Taxoids/administration & dosage , Taxoids/adverse effects , Treatment OutcomeABSTRACT
This phase I-II trial was designed to assess the effect of irinotecan on oxaliplatin pharmacokinetics and to determine the MDT of both drugs when administered in combination. Treatment was repeated every 2 weeks. Pharmacokinetic studies were performed on cycle 1 and 2 to assess the best sequence and detect any interaction between the two drugs. Thirty-four patients with advanced colorectal cancer were enrolled; 28 of them (82%) had liver involvement. The main toxicities were neutropenia and delayed diarrhea; 5 patients (14%) experienced febrile neutropenia. Dose-limiting toxicity was experienced at levels 1/2/3/4/5 by 4/10, 1/6, 3/6, 3/8, and 3/4 patients, respectively. Fifteen patients responded (2 CR; 13 PR) for an ORR of 44%. No pharmacokinetic interactions between irinotecan and oxaliplatin were detected. The recommended dose for future phase II trials is oxaliplatin 85 mg/m and irinotecan 180 mg/m2 on day 1 combined with 5FU/leucovorin according to the de Gramont regimen at days 2 and 3. Twenty-nine percent of patients underwent secondary hepatectomy with curative intent, and two of them are long-term disease-free survivors. It would appear that the dose and schedule defined by this trial could be proposed as front-line therapy for advanced colorectal carcinoma to establish rapid disease control and to permit patients to proceed to surgery.
