Methods:
All adolescent and adult OGS and ES cases treated at Tata Memorial Centre, Mumbai, with the “OGS-12” and Ewing’s family of tumors-2001 (“EFT-2001”) protocol from November 2011 to January 2021, and January 2013 to November 2018 respectively were prospectively analyzed separately. The “OGS-12” protocol consists of doublets of doxorubicin, ifosfamide and cisplatin given sequentially for eight cycles in both neoadjuvant (NACT) and adjuvant (ACT) settings. The “EFT-2001” protocol consists of a 12-month course of ifosfamide plus etoposide and vincristine, doxorubicin plus cyclophosphamide. Demographic factors recorded were age, gender and nutritional parameters. Disease factors were symptom duration, lactate dehydrogenase (LDH), serum alkaline phosphatase (SAP), tumor size, presence and sites of metastases, pathological fracture and neurovascular bundle involvement. Patients were stratified based on age into the following categories: 15-25 and >25-39 to evaluate prognostic significance of age. Patients with metastatic disease were stratified into categories based on number (<=10, >10), location (lung, bone, or other) and whether metastases were amenable to local treatment based on multimodality joint clinic discussion. Toxicities were documented using the US National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0. Histological response on the surgical specimen was assessed using Huvo’s necrosis grading, wherein good responders were defined as those with <10% viable cells [11].
Treatment characteristics recorded recorded from electronic medical records (EMR) included markers of non-compliance (failure to complete protocol and failure to complete treatment within the planned period with 25% additional time to allow for justifiable reasons for non-compliance), prior inadvertent treatment by peripheral practitioners, and febrile neutropenia as a marker of chemosensitivity.
The study was conducted in accordance with ethical principles outlined in the Declaration of Helsinki (Fortaleza, Brazil 2013), ICH-GCP, European Directive 2001/20/EC, US Code of Federal Regulations, South African Good Clinical Practice Guidelines, and other institutional regulatory requirements. Data collection and analyses were conducted in a single institution. This study is registered with Clinical Trials Registry—India (CTRI) identifier: CTRI/2023/10/059247.