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.