Real-World Experience in Toxicity with Bevacizumab in Indian Cancer Patients

Our plain-English summary of Real-World Experience in Toxicity with Bevacizumab in Indian Cancer Patients, by P.P. Patil, R.R. Rangaraju, W. Abbas, et al (South Asian Journal of Cancer, 2021).

The study

• Authors: P.P. Patil, R.R. Rangaraju, W. Abbas, S. Garg
• Journal: South Asian Journal of Cancer
• Published: 2021;10(2):131-134
• Cited by: 5 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

Background Bevacizumab, a humanized monoclonal antibody, known to block the binding of all known vascular endothelial growth factor-A isomers to their receptors, is used in solid cancers, especially in advanced settings where its role is proven to be stronger than localized stages. Furthermore, various studies have suggested that adding bevacizumab to first-line standard therapy in advanced solid cancers, such as colorectal cancer, lung cancer, ovarian cancer, renal cancer, and breast cancer, significantly prolongs progression-free survival, overall survival, and response rates. However, this ability is limited and variable in cancer subtype. The toxicity profile of bevacizumab is outspread, ranging from mild gastrointestinal side effects, proteinuria to life-threatening hemorrhagic tendency, ischemic thromboembolism, and intestinal perforation. However, it has never been studied in Indian subset of patients till date. Materials and Methods We performed an institutional retrospective study of 41 patients with a pathologically proven ovarian, colorectal, lung, mesothelioma, melanoma, round cell tumors, and GBMs who received bevacizumab (2.5 mg/kg/week [5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks]) with or without chemotherapy, between January 2016 and January 2019 at our center in North India. Results Forty-one patients, including 12 (29) advanced ovarian cancer, 12 (29) colon cancer, 10 (24) rectal cancer, 1 (2) appendicular cancer, 1 (2) mesothelioma, 1 (2) melanoma, 1 (2) desmoplastic round cell tumor, and 3 (7) GBM, were treated with bevacizumab. The incidence of arterial thrombus and hemorrhage was 2 and 10%, respectively, whereas venous thrombus and fistula were not seen and not related to age. No fatal adverse event was recorded. The global incidence of severe (grade 3/4) arterial hypertension (HTN) was 49%. It was safely managed in all cases, and no grade 4 (life-threatening complication) occurred. The incidence of severe HTN was significantly higher in elderly patients than in younger ones (72 vs. 40%), proteinuria was found to be more frequent in the younger age group as compared with older age group (7 vs. 3%). Also to note, the incidence of congestive heart failure and subacute intestinal obstruction was found in 5% of patients, wherein all four patients belonged to the older subgroup. Furthermore, Grade 3 hypersensitivity reaction was found in one patient in the younger subgroup which warranted immediate termination of bevacizumab.

MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

In plain English

This was a retrospective study of the records of 41 cancer patients treated with the drug bevacizumab, with or without chemotherapy, at one hospital in New Delhi, India, between January 2016 and January 2019. It is not a study of asbestos. Only one patient had mesothelioma, the article does not say whether it was pleural or peritoneal, and asbestos exposure is not discussed. Most patients had ovarian, colon or rectal cancer. The authors looked at serious side effects according to age. Arterial blood clots occurred in 2% of patients and bleeding in 10%. No venous clots, no fistulas and no deaths from side effects were recorded. Severe (grade 3 or 4) high blood pressure occurred in 49% overall, in 72% of patients over 65 and in 40% of younger patients. There were no life-threatening (grade 4) cases. Heart failure and bowel obstruction were found only in older patients. Some figures in the text and tables disagree, including those for protein in the urine. The authors concluded that age itself did not appear to be a reason to avoid bevacizumab.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: single-institution retrospective study of hospital records
• Who was studied: 41 patients treated at Max Super Speciality Hospital, Shalimar Bagh, New Delhi, India, between January 2016 and January 2019: 12 advanced ovarian cancer, 12 colon cancer, 10 rectal cancer, 1 appendicular cancer, 1 mesothelioma, 1 melanoma, 1 desmoplastic round cell tumor and 3 GBM. 30 patients were under 65 and 11 were over 65.
• Exposure: The drug bevacizumab at a dosage intensity of 2.5 mg/kg/week (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks), with or without chemotherapy. No asbestos or fiber exposure was studied.
• Main results:
  • In all 41 patients, the incidence of arterial thrombus was 2% and of hemorrhage 10%. No venous thrombus or fistula was seen.
  • No fatal adverse event was recorded.
  • Severe (grade 3/4) arterial hypertension occurred in 49% of all patients (20 of 41). The authors reported it was safely managed in all cases, and no grade 4 events occurred.
  • Severe hypertension was reported as significantly higher in patients over 65 (72%, 8 of 11) than in patients under 65 (40%, 12 of 30). No statistical test is described.
  • The text says proteinuria was more frequent in the younger group (7 vs. 3%). Table 2 instead lists 1 (3%) of patients under 65 and 2 (18%) of patients over 65, with 3 (7%) overall.
  • Congestive heart failure and subacute intestinal obstruction were each found in 2 patients (5%). All four of these patients were in the older subgroup.
  • One patient in the younger subgroup had a grade 3 hypersensitivity reaction, and bevacizumab was stopped immediately.
• The authors' conclusion: The authors concluded that age itself did not appear to be a contraindication for bevacizumab. They added that with well-adjusted risk assessment and careful follow-up of hypertension, it could be used safely in older patients.

Topics

Medical terms in this study, explained in our Lexicon: Bevacizumab, Monoclonal Antibody, Colorectal Cancer, Lung Cancer, Ovarian Cancer, Progression-Free Survival, Overall Survival, Mesothelioma.

Related studies

• First-Line Nivolumab Plus Ipilimumab in Inoperable Epithelioid Malignant Pleural Mesothelioma: Real-World Experience From an Indian Tertiary Care Center — A. Shah, A. Agarwal, et al. (2026)
• Multimodal Treatment of Malignant Pleural Mesothelioma: Real-World Experience with 112 Patients — A. Holzknecht, O. Illini, et al. (2022)
• Nivolumab in pre-treated malignant pleural mesothelioma: real-world data from the Dutch expanded access program — L. Cantini, R.A. Belderbos, et al. (2020)
• I-O Optimise: a novel multinational real-world research platform in thoracic malignancies — S. Ekman, F. Griesinger, et al. (2019)
• A Real-World Analysis of the Use of Systemic Therapy in Malignant Pleural Mesothelioma and the Differential Impacts on Overall Survival by Practice Pattern — K. Kerrigan, Y. Jo, et al. (2022)
• Efficacy of chemotherapy for malignant pleural mesothelioma according to histology in a real-world cohort — S. Cedres, J.D. Assaf, et al. (2021)

Browse return to medical research.