Evaluating the landscape of PD-L1 testing and treatment approaches in gastrointestinal and lung cancer: a questionnaire-based study among Indian oncologists
DOI:
https://doi.org/10.18203/2320-6012.ijrms20261333Keywords:
PD-L1 testing, Immunotherapy, Lung cancer, Gastrointestinal malignancies, Biomarker testingAbstract
Background: Lung and gastrointestinal (GI) cancers together account for a major proportion of India’s cancer burden, with most cases diagnosed at advanced stages. Despite the proven efficacy of immune checkpoint inhibitors (ICIs), access and biomarker-guided implementation remain limited. This study assessed the current landscape of PD-L1 testing and immunotherapy (IO) practices among Indian oncologists treating patients with lung and GI malignancies.
Methods: A cross-sectional, questionnaire-based survey was conducted among 63 practicing oncologists across India from February 2025 to April 2025. The 23-item questionnaire collected information on PD-L1 testing practices, immuno-oncology (IO) usage, and barriers to adoption. Data were analyzed using descriptive statistics.
Results: Most respondents (73.02%) had over 10 years of clinical experience. PD-L1 testing was most frequent in non-small cell lung cancer (NSCLC) and less consistent in GI malignancies. Immunotherapy use was highest in NSCLC (44.44% common use in first-line) and hepatocellular carcinoma (36.51%), but infrequent in colorectal and biliary tract cancers. High PD-L1 expression guided IO use in most cases, while actionable mutations and performance status also influenced treatment choice. Cost was the predominant barrier, with 56-70% of patients deferring IO due to financial constraints. Key unmet needs included affordable access to IO (95.24%), predictive biomarkers (58.73%), and India-specific clinical guidelines (57.14%). Experienced oncologists were more likely to consider IO re-challenge after progression (p=0.03).
Conclusions: PD-L1 testing and IO adoption remain inconsistent across India, primarily due to cost, infrastructure, and limitations in biomarker availability. Strategic measures such as subsidized access, standardized testing, and context-adapted guidelines are essential to advance equitable precision immunotherapy in Indian oncology practice.
Metrics
References
Group NCRPI, Mathur P, Sathishkumar K, Das P, Santhappan S, Sankarapillai J, et al. Cancer Incidence and Mortality Across 43 Cancer Registries in India. JAMA Netw Open. 2025;8(8):e2527805. DOI: https://doi.org/10.1001/jamanetworkopen.2025.3910
Sathishkumar K, Chaturvedi M, Das P, Stephen S, Mathur P. Cancer incidence estimates for 2022 & projection for 2025: Result from National Cancer Registry Programme, India. Indian J Med Res. 2023;156(4-5):598. DOI: https://doi.org/10.4103/ijmr.ijmr_1821_22
Ramnath N, Ganesan P, Penumadu P, Arenberg D, Bryant A, Ramnath N, et al. Lung cancer screening in India: Preparing for the future using smart tools & biomarkers to identify highest risk individuals. Indian J Med Res. 2025;160(6):561-9. DOI: https://doi.org/10.25259/ijmr_118_24
Singh K, Grover A, Dhanasekaran K. Unveiling the cancer epidemic in India: a glimpse into GLOBOCAN 2022 and past patterns. The Lancet Regional Health - Southeast Asia. 2025;34:100546. DOI: https://doi.org/10.1016/j.lansea.2025.100546
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424. DOI: https://doi.org/10.3322/caac.21492
Sekar A, Rajendra A, Noronha V, Mokal S, Patil VM, Menon N, et al. The epidemiological trend of esophageal cancer in Mumbai, India over the past two decades. Journal of Clinical Oncology. 2021;39(15):e16095. DOI: https://doi.org/10.1200/JCO.2021.39.15_suppl.e16095
Gopalakrishna H, Huang B, Mathew A. Incidence of hepatocellular cancer in India: Analysis of population based cancer registry data. J Clin Oncol. 2023;41(16):e16233. DOI: https://doi.org/10.1200/JCO.2023.41.16_suppl.e16233
Shivshankar S, Patil PS, Deodhar K, Budukh AM. Epidemiology of colorectal cancer: A review with special emphasis on India. Indian J Gastroenterol. 2025;44(2):142-53. DOI: https://doi.org/10.1007/s12664-024-01726-8
Thomas VM, Baby B, Wang K, Lei F, Chen Q, Huang B, et al. Trends in colorectal cancer incidence in India. Journal of Clinical Oncology. 2020;38(15):e16084. DOI: https://doi.org/10.1200/JCO.2020.38.15_suppl.e16084
Anand U, Dey A, Chandel AKS, Sanyal R, Mishra A, Pandey DK, et al. Cancer chemotherapy and beyond: Current status, drug candidates, associated risks and progress in targeted therapeutics. Genes Dis. 2023;10(4):1367-401. DOI: https://doi.org/10.1016/j.gendis.2022.02.007
Shiravand Y, Khodadadi F, Kashani SMA, Hosseini-Fard SR, Hosseini S, Sadeghirad H, et al. Immune Checkpoint Inhibitors in Cancer Therapy. Curr Oncol. 2022;29(5):3044. DOI: https://doi.org/10.3390/curroncol29050247
Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Gao S, et al. Perioperative Pembrolizumab for Early-Stage Non–Small-Cell Lung Cancer. N Engl J Med. 2023;389(6):491-503. DOI: https://doi.org/10.1056/NEJMoa2302983
Cascone T, Awad MM, Spicer JD, He J, Lu S, Sepesi B, et al. Perioperative Nivolumab in Resectable Lung Cancer. N Engl J Med. 2024;390(19):1756-69. DOI: https://doi.org/10.1056/NEJMoa2311926
Reck M, Nadal E, Girard N, Filippi AR, Martin LW, Gay CM, et al. MDT-BRIDGE: Neoadjuvant Durvalumab Plus Chemotherapy Followed by Either Surgery and Adjuvant Durvalumab or Chemoradiotherapy and Consolidation Durvalumab in Resectable or Borderline-resectable Stage IIB–IIIB NSCLC. Clin Lung Cancer. 2024;25(6):587-93. DOI: https://doi.org/10.1016/j.cllc.2024.06.007
Yue D, Wang W, Liu H, Chen Q, Chen C, Liu L, et al. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial. Lancet Respir Med. 2025;13(2):119-29. DOI: https://doi.org/10.1016/S2213-2600(24)00269-8
Spigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, et al. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022;40(12):1301-11. DOI: https://doi.org/10.1200/JCO.21.01308
Aoun Bacha Z, Bitar N, Saleh WA, Assi H, Bahous J, Boukhalil P, et al. Diagnosis and management of patients with stage III non small cell lung cancer: A joint statement by the Lebanese Society of Medical Oncology and the Lebanese Pulmonary Society (Review). Oncol Lett. 2023;25(3):113. DOI: https://doi.org/10.3892/ol.2023.13699
Jaiyesimi IA, Leighl NB, Ismaila N, Alluri K, Florez N, Gadgeel S, et al. Therapy for Stage IV Non-Small Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline, Version 2023.3. J Clin Oncol. 2024;42(11):E23-43. DOI: https://doi.org/10.1200/JCO.23.02746
Lertbutsayanukul C, Tharavej C, Klaikeaw N, Prayongrat A, Lowanitchai C, Sriuranpong V. High dose radiation with chemotherapy followed by salvage esophagectomy among patients with locally advanced esophageal squamous cell carcinoma. Thorac Cancer. 2017;8(3):219-28. DOI: https://doi.org/10.1111/1759-7714.12427
Kato K, Cho BC, Takahashi M, Okada M, Lin CY, Chin K, et al. Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019;20(11):1506-17. DOI: https://doi.org/10.1016/S1470-2045(19)30626-6
Moehler M, Shitara K, Garrido M, Salman P, Shen L, Wyrwicz L, et al. LBA6_PR Nivolumab (nivo) plus chemotherapy (chemo) versus chemo as first-line (1L) treatment for advanced gastric cancer/ gastroesophageal junction cancer (GC/GEJC)/ esophageal adenocarcinoma (EAC): First results of the CheckMate 649 study. Ann Oncol. 2020;31:S1191. DOI: https://doi.org/10.1016/j.annonc.2020.08.2296
Boku N, Ryu MH, Oh DY, Oh SC, Chung HC, Lee KW, et al. LBA7_PR Nivolumab plus chemotherapy versus chemotherapy alone in patients with previously untreated advanced or recurrent gastric/ gastroesophageal junction (G/GEJ) cancer: ATTRACTION-4 (ONO-4538-37) study. Ann Oncol. 2020;31:S1192. DOI: https://doi.org/10.1016/j.annonc.2020.08.2297
Xu J, Kato K, Raymond E, Hubner RA, Shu Y, Pan Y, et al. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2023;24(5):483-95. DOI: https://doi.org/10.1016/S1470-2045(23)00108-0
Shen L, Kato K, Kim SB, Ajani JA, Zhao K, He Z, et al. Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomized Phase III Study. J Clin Oncol. 2022;40(26). DOI: https://doi.org/10.1200/JCO.2022.40.4_suppl.279
Qiu MZ, Oh DY, Kato K, Arkenau T, Tabernero J, Correa MC, et al. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. BMJ. 2024;385. DOI: https://doi.org/10.1136/bmj-2023-078876
Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, et al. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020;382(20):1894-905. DOI: https://doi.org/10.1056/NEJMoa1915745
Abou-Alfa GK, Lau G, Kudo M, Chan SL, Kelley RK, Furuse J, et al. Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma. NEJM Evidence. 2022;1(8). DOI: https://doi.org/10.1056/EVIDoa2100070
Oh DY, He AR, Bouattour M, Okusaka T, Qin S, Chen LT, et al. Durvalumab or placebo plus gemcitabine and cisplatin in participants with advanced biliary tract cancer (TOPAZ-1): updated overall survival from a randomised phase 3 study. Lancet Gastroenterol Hepatol. 2024;9(8):694-704. DOI: https://doi.org/10.1016/S2468-1253(24)00095-5
Merck.com. Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy in First-Line Advanced or Unresectable Biliary Tract Cancer in KEYNOTE-966 Trial. Available at: https://www.merck.com/news/mercks-keytruda-pembrolizumab-plus-chemotherapy-significantly-improved-overall-survival-versus-chemotherapy-in-first-line-advanced-or-unresectable-biliary-tract-cancer-in-keynote-966/. Accessed on 28 August 2025.
Battaglin F, Naseem M, Lenz HJ, Salem ME. Microsatellite Instability in Colorectal Cancer: Overview of Its Clinical Significance and Novel Perspectives. Clin Adv Hematol Oncol. 2018;16(11):735.
Default Digital Object Group. CheckMate-8HW: Nivolumab/Ipilimumab Demonstrates Improved Outcomes Over Standard Therapies in MSI-H/dMMR mCRC. 2025. Available at: https://dailynews.asco pubs.org/do/10.1200/adn.25.300026/abs/. Accessed on 28 August 2025.
De Marchi P, Leal LF, Duval Da Silva V, Da Silva ECA, Cordeiro De Lima VC, Reis RM. PD-L1 expression by Tumor Proportion Score (TPS) and Combined Positive Score (CPS) are similar in non-small cell lung cancer (NSCLC). J Clin Pathol. 2021;74(11):735-40. DOI: https://doi.org/10.1136/jclinpath-2020-206832
Wang Z, Zou X, Wang H, Hao Z, Li G, Wang S. Companion diagnostics and predictive biomarkers for PD-1/PD-L1 immune checkpoint inhibitors therapy in malignant melanoma. Front Immunol. 2024;15. DOI: https://doi.org/10.3389/fimmu.2024.1454720
Moehler M, Yoon HH, Wagner DC, Yang S, Shi J, Zhang Y, et al. Concordance Between the PD-L1 Tumor Area Positivity Score and Combined Positive Score for Gastric or Esophageal Cancers Treated With Tislelizumab. Modern Pathol. 2025;38(9). DOI: https://doi.org/10.1016/j.modpat.2025.100793
Vranic S, Gatalica Z. PD-L1 testing by immunohistochemistry in immuno-oncology. Biomol Biomed. 2023;23(1):15. DOI: https://doi.org/10.17305/bjbms.2022.7953
Patil V, Abraham G, Ravikrishna M, Bhattacharjee A, Noronha V, Parekh D, et al. Retrospective analysis: checkpoint inhibitor accessibility for thoracic and head and neck cancers and factors influencing it in a tertiary centre in India. Ecancermedicalscience. 2022;16. DOI: https://doi.org/10.3332/ecancer.2022.1464
Davis AA, Patel VG. The role of PD-L1 expression as a predictive biomarker: an analysis of all US Food and Drug Administration (FDA) approvals of immune checkpoint inhibitors. J Immunother Cancer. 2019;7(1):278. DOI: https://doi.org/10.1186/s40425-019-0768-9
Eysenbach G. Improving the Quality of Web Surveys: The Checklist for Reporting Results of Internet E-Surveys (CHERRIES). J Med Internet Res. 2004;6(3):e34. DOI: https://doi.org/10.2196/jmir.6.3.e34
Ngo P, Cooper WA, Wade S, Fong KM, Canfell K, Karikios D, et al. Why PD-L1 expression varies between studies of lung cancer: results from a Bayesian meta-analysis. Sci Rep. 2025;15(1):1-10. DOI: https://doi.org/10.1038/s41598-024-80301-9
Mastracci L, Grillo F, Parente P, Gullo I, Campora M, Angerilli V, et al. PD-L1 evaluation in the gastrointestinal tract: from biological rationale to its clinical application. Pathologica. 2022;114(5):352. DOI: https://doi.org/10.32074/1591-951X-803
Parra-Medina R, Castañeda-González JP, Montoya L, Gómez-Gómez MP, Cabezas DC, Vargas MP. PD-L1 expression in non-small cell lung carcinoma in Latin America: a systematic review and meta-analysis. Transl Lung Cancer Res. 2024;13(7):1660-71. DOI: https://doi.org/10.21037/tlcr-24-223
Pagliuso J, Parry S, Haffajee Z, Badrick T, Miller K. The challenges of implementing a PD-L1 proficiency testing program in Australia. Vasc Cell. 2018;10(1). DOI: https://doi.org/10.24238/13221-10-1-180
Gosney JR, Peake MD, Kerr KM. Improving practice in PD-L1 testing of non-small cell lung cancer in the UK: current problems and potential solutions. J Clin Pathol. 2024;77(2):135-9. DOI: https://doi.org/10.1136/jcp-2022-208643
Noronha V, Abraham G, Patil V, Joshi A, Menon N, Mahajan A, et al. A real-world data of Immune checkpoint inhibitors in solid tumors from India. Cancer Med. 2021;10(5):1525-34. DOI: https://doi.org/10.1002/cam4.3617
Hu-Lieskovan S, Lisberg A, Zaretsky JM, Grogan TR, Rizvi H, Wells DK, et al. Tumor Characteristics Associated with Benefit from Pembrolizumab in Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2019;25(16):5061-8. DOI: https://doi.org/10.1158/1078-0432.CCR-18-4275
Guo X, Du H, Li J, Yang M, Xiong A, Zhang H, et al. Efficacy of ICIs on patients with oncogene-driven non-small cell lung cancer: a retrospective study. Cancer Drug Resist. 2022;5(1):15-24. DOI: https://doi.org/10.20517/cdr.2021.85
Miyasato G, Shah C, Gorsuch T, Venkateswaran R, Kasivajjala VC, Misra M. Addressing the affordability gap of novel cancer treatments in developing countries. PLOS Digital Health. 2024;3(5):e0000488. DOI: https://doi.org/10.1371/journal.pdig.0000488
Patel A, Hande V, MR K, Dange H, Das AK, Murugesan V, et al. Effectiveness of Immune Checkpoint Inhibitors in Various Tumor Types Treated by Low, Per-Weight, and Conventional Doses at a Tertiary Care Center in Mumbai. JCO Glob Oncol. 2024;(10). DOI: https://doi.org/10.1200/GO.23.00312
Majem M. LBA3 Perioperative pembrolizumab (pembro) plus neoadjuvant chemotherapy (chemo) in early-stage non-small-cell lung cancer (NSCLC): A 4-year update of KEYNOTE-671. Immuno-Oncol Technol. 2024;24:101027. DOI: https://doi.org/10.1016/j.iotech.2024.101027
Hektoen HH, Tsuruda KM, Brustugun OT, Neumann K, Andreassen BK. Real-world comparison of pembrolizumab alone and combined with chemotherapy in metastatic lung adenocarcinoma patients with PD-L1 expression ≥50%. ESMO Open. 2025;10(5):105073. DOI: https://doi.org/10.1016/j.esmoop.2025.105073
Waterhouse DM, Garon EB, Chandler J, McCleod M, Hussein M, Jotte R, et al. Continuous Versus 1-Year Fixed-Duration Nivolumab in Previously Treated Advanced Non–Small-Cell Lung Cancer: CheckMate 153. J Clin Oncol. 2020;38(33):3863. DOI: https://doi.org/10.1200/JCO.20.00131
Rimassa L, Chan SL, Sangro B, Lau G, Kudo M, Reig M, et al. Five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable HCC. J Hepatol. 2025;83(4):899-908. DOI: https://doi.org/10.1016/j.jhep.2025.03.033
André T, Elez E, Van Cutsem E, Jensen LH, Bennouna J, Mendez G, et al. Nivolumab plus Ipilimumab in Microsatellite-Instability–High Metastatic Colorectal Cancer. N Eng J Med. 2024;391(21):2014-26. DOI: https://doi.org/10.1056/NEJMoa2402141
Qin S, Bai Y, Li J, Pan H, Luo S, Qu Y, et al. First-Line Pembrolizumab Plus Chemotherapy for HER2-Negative Advanced Gastric Cancer: China Subgroup Analysis of the Randomized Phase 3 KEYNOTE-859 Study. Adv Ther. 2025;42(4):1892-906. DOI: https://doi.org/10.1007/s12325-024-03069-4
Liu T, Feng Y, Xu X, Ren X, Jia J, Pan H, et al. 1049P Phase Ib/II trial of envafolimab, a novel subcutaneous single-domain anti-PD-L1 monoclonal antibody, plus lenvatinib in patients with selected advanced solid tumors. Ann Onc. 2023;34:S635. DOI: https://doi.org/10.1016/j.annonc.2023.09.2188
Liu SJ, Yan LJ, Wang HC, Ding ZN, Liu H, Zhang X, et al. Safety, efficacy, and survival outcomes of immune checkpoint inhibitors rechallenge in patients with cancer: a systematic review and meta-analysis. Oncologist. 2024;29(11):e1425-34. DOI: https://doi.org/10.1093/oncolo/oyae134
Xu S, Shukuya T, Tamura J, Shimamura S, Kurokawa K, Miura K, et al. Heterogeneous Outcomes of Immune Checkpoint Inhibitor Rechallenge in Patients With NSCLC: A Systematic Review and Meta-Analysis. JTO Clin Res Rep. 2022;3(4):100309. DOI: https://doi.org/10.1016/j.jtocrr.2022.100309
Rodler S, Aydogdu C, Brinkmann I, Berg E, Kopliku R, Götz M, et al. Toxicity-Induced Discontinuation of Immune Checkpoint Inhibitors in Metastatic Urothelial Cancer: 6-Year Experience from a Specialized Uro-Oncology Center. Cancers (Basel). 2024;16(12):2246. DOI: https://doi.org/10.3390/cancers16122246
Cook S, Samuel V, Meyers DE, Stukalin I, Litt I, Sangha R, et al. Immune-Related Adverse Events and Survival Among Patients With Metastatic NSCLC Treated With Immune Checkpoint Inhibitors. JAMA Netw Open. 2024;7(1):e2352302. DOI: https://doi.org/10.1001/jamanetworkopen.2023.52302
Downloads
Published
How to Cite
Issue
Section
