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1.
Nature ; 629(8014): 1142-1148, 2024 May.
Article in English | MEDLINE | ID: mdl-38588696

ABSTRACT

PARTNER is a prospective, phase II-III, randomized controlled clinical trial that recruited patients with triple-negative breast cancer1,2, who were germline BRCA1 and BRCA2 wild type3. Here we report the results of the trial. Patients (n = 559) were randomized on a 1:1 basis to receive neoadjuvant carboplatin-paclitaxel with or without 150 mg olaparib twice daily, on days 3 to 14, of each of four cycles (gap schedule olaparib, research arm) followed by three cycles of anthracycline-based chemotherapy before surgery. The primary end point was pathologic complete response (pCR)4, and secondary end points included event-free survival (EFS) and overall survival (OS)5. pCR was achieved in 51% of patients in the research arm and 52% in the control arm (P = 0.753). Estimated EFS at 36 months in the research and control arms was 80% and 79% (log-rank P > 0.9), respectively; OS was 90% and 87.2% (log-rank P = 0.8), respectively. In patients with pCR, estimated EFS at 36 months was 90%, and in those with non-pCR it was 70% (log-rank P < 0.001), and OS was 96% and 83% (log-rank P < 0.001), respectively. Neoadjuvant olaparib did not improve pCR rates, EFS or OS when added to carboplatin-paclitaxel and anthracycline-based chemotherapy in patients with triple-negative breast cancer who were germline BRCA1 and BRCA2 wild type. ClinicalTrials.gov ID: NCT03150576 .


Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Neoadjuvant Therapy , Phthalazines , Piperazines , Triple Negative Breast Neoplasms , Adult , Aged , Female , Humans , Middle Aged , Anthracyclines/therapeutic use , Anthracyclines/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carboplatin/administration & dosage , Carboplatin/therapeutic use , Genes, BRCA1 , Genes, BRCA2 , Paclitaxel/administration & dosage , Paclitaxel/therapeutic use , Pathologic Complete Response , Phthalazines/administration & dosage , Phthalazines/therapeutic use , Piperazines/administration & dosage , Piperazines/therapeutic use , Progression-Free Survival , Prospective Studies , Survival Analysis , Time Factors , Triple Negative Breast Neoplasms/drug therapy , Triple Negative Breast Neoplasms/metabolism , Triple Negative Breast Neoplasms/surgery , Adolescent , Young Adult
2.
Future Oncol ; 11(2): 193-203, 2015.
Article in English | MEDLINE | ID: mdl-25040106

ABSTRACT

BACKGROUND: N-acetyl-glucosaminidase (NAG) is a potential marker of genotoxicity. We retrospectively analyzed plasma NAG and clinico-pathologic features in advanced gastrointestinal adenocarcinoma patients. METHODS: Plasma from 118 patients and 51 healthy volunteers was analyzed for associations between NAG levels and age, disease presence, stage, treatment responses and survival. RESULTS: Pretreatment NAG correlated with age but was independently increased in metastatic versus locally advanced disease, particularly in gastric/esophageal patients. NAG was also associated with reduced overall survival. In subgroup analysis, increased NAG activity between day 1 and 2 of chemotherapy cycle 1 correlated with treatment response. CONCLUSION: We demonstrated that NAG correlates with gastrointestinal cancer outcomes. Further studies are required to determine if plasma markers of genotoxicity can be useful for disease monitoring.


Subject(s)
Acetylglucosaminidase/blood , Adenocarcinoma/blood , Colorectal Neoplasms/blood , Esophageal Neoplasms/blood , Stomach Neoplasms/blood , Adenocarcinoma/drug therapy , Adenocarcinoma/mortality , Adenocarcinoma/secondary , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Case-Control Studies , Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/mortality , Colorectal Neoplasms/pathology , Esophageal Neoplasms/drug therapy , Esophageal Neoplasms/mortality , Esophageal Neoplasms/pathology , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Stomach Neoplasms/drug therapy , Stomach Neoplasms/mortality , Stomach Neoplasms/pathology , Treatment Outcome , Young Adult
3.
Sarcoma ; 9(3-4): 157-60, 2005.
Article in English | MEDLINE | ID: mdl-18521425

ABSTRACT

Skin toxicity is a common side-effect of treatment with imatinib mesylate (STI571, Glivectrade mark) in advanced gastrointestinal stromal tumours (GIST) and chronic myeloid leukaemia. The optimal duration of treatment with imatinib mesylate in GIST has not yet been established, as durable remissions have been observed in patients. It is, therefore, important to develop strategies to deal with common side-effects of what may be a long-term treatment. Here we report the case of a patient with advanced GIST who developed a cutaneous drug reaction secondary to imatinib mesylate and the various management options that may be employed depending upon the severity of the toxicity. The case and literature are discussed.

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