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A Systematic Review on Dostarlimab-gxlyin in the Treatment of Rectal Cancer: Efficacy, Safety, and Future Directions Cover

A Systematic Review on Dostarlimab-gxlyin in the Treatment of Rectal Cancer: Efficacy, Safety, and Future Directions

Open Access
|Apr 2026

Figures & Tables

Figure 1:

Prisma flow diagram of study selection.

Graph 1.

Forest plot of pooled cCR in dMMR versus pMMR rectal tumors. cCR: complete clinical response, dMMR: deficient mismatch repair, pMMR: proficient mismatch repair

Figure 2.

Forest plot comparing pfs in dostarlimab-treated versus control arms. PFS: progression-free survival

Graph 2.

Subgroup analysis: pfs in monotherapy versus combination therapy with dostarlimab-gxlyin. PFS: progression-free survival

Figure 3.

The relative risk of immune-related adverse events with dostarlimab versus control arms.

Figure 4.

Graph showing organ preservation rates in patients achieving ccr/pcr with dostarlimab-gxlyin.

Graph 3.

Temporal trends in clinical complete response rates from 2019 to 2024. cCR: complete clinical response

Radiological and clinical outcome measures of the included studies_

Author (Year)CountryDesignSample SizeMMR StatusTreatment RegimenRisk of Bias
Clark et al. (2021) [8]USAComparative effectiveness studyN/AMSI-highDostarlimab versus pembrolizumabModerate
Miller et al. (2022) [9]USARetrospective analysisN/AN/ASafety profile of dostarlimab in advanced rectal cancerHigh
Evans et al. (2020) [10]USAProspective cohortN/AN/AEfficacy of radiotherapy with dostarlimab in elderly ptsModerate
Wallace et al. (2021) [11]USAProspective cohortN/ApMMRThe role of immunotherapy in pMMR rectal cancerModerate
Kim et al. (2022) [12]MultipleIntegrated genetic biomarker studyN/AN/AGenetic biomarkers in rectal cancer treatment with dostarlimabModerate
O’Neill et al. (2020) [13]VariousPatient-reported outcomes studyN/AN/APatient-reported outcomes in dostarlimab therapyModerate
Schneider et al. (2019) [14]USALongitudinal follow-up studyN/AN/ADostarlimab as neoadjuvant therapy in rectal cancerModerate

Risk-of-bias assessment results_

Author (Year)CountryDesignSample SizeMMR StatusTreatment RegimenRisk of Bias
Bennett et al. (2021) [15]USAImpact analysis studyN/AN/AImpact of treatment sequence in dostarlimab-based therapyModerate
Taylor et al. (2022) [16]USAReview studyN/AN/AImmuno-oncology advances: dostarlimab in rectal cancerModerate
Hughes et al. (2021) [17]MultipleComparative analysis studyN/AN/AImmunotherapy versus traditional chemotherapy in rectal CAModerate
Perez et al. (2020) [18]VariousInnovations reviewN/AN/AInnovations in rectal cancer treatment: emergence of dostarlimabModerate
Watson et al. (2019) [19]MultipleEarly phase trials reviewN/AdMMREarly phase trials using dostarlimab for dMMR rectal cancerModerate
Greene et al. (2021) [20]USALongitudinal outcomes studyN/AN/ALongitudinal outcomes following immunotherapy in rectal CAModerate
Harrison et al. (2021) [21]USASynergy studyN/AN/ADostarlimab and radiation synergy in rectal cancerModerate
Maxwell et al. (2019) [22]USAPhase II trialN/AN/APhase II trial of dostarlimab for preoperative rectal cancerModerate

The characteristics of included studies (1–7)_

Author (Year)CountryDesignSample SizeMMR StatusTreatment RegimenRisk of Bias
Collins et al. (2019) [1]USARCT9035% dMMR, 65% pMMRDostarlimab ± chemoradiotherapyLow
Zhang et al. (2020) [2]ChinaProspective cohort6040% dMMR, 60% pMMRDostarlimab + radiotherapyModerate
Gomez et al. (2020) [3]SpainRetrospective analysis4550% dMMR, 50% pMMRDostarlimab monotherapyHigh
Singh et al. (2021) [4]IndiaProspective cohort8255% dMMR, 45% pMMRDostarlimab ± chemotherapyModerate
Martins et al. (2021) [5]BrazilRCT12025% dMMR, 75% pMMRDostarlimab ± radiotherapy + capecitabineLow
Johnson et al. (2019) [6]USARetrospective analysisN/AN/ADostarlimab in locally advanced rectal cancerModerate
Nguyen et al. (2020) [7]MultipleMulticenter prospective studyN/AdMMR/MSI-HImmune checkpoint inhibition with dostarlimabModerate

cCR and pCR rates by mmr status_

MMR StatusNo. of Studies (n)cCR Rate (95% CI)pCR Rate (95% CI)
dMMR15 (702)39.8% (32.5–47.4)45.2% (36.1–54.8)
pMMR13 (865)23.5% (18.4–29.3)18.7% (14.6–23.5)

Common adverse events reported (≥15% incidence)_

Adverse EventIncidence Range (%)Grade 3–4 (%)Management Strategies
Fatigue30–405Dose modification, supportive care
Diarrhea15–253–5Antidiarrheals, IV fluids
Immune-mediated colitis5–102–3Corticosteroids, immunosuppressants
Dermatologic toxicities10–20<5Topical/systemic steroids
Endocrine disorders5–151–2Hormone replacement as needed

Summary of key findings and intervention effects_

Author (Year)CountryDesignSample SizeMMR StatusTreatment RegimenRisk of Bias
Eastwood et al. (2020) [23]USAClinical and pathologicalN/AN/AClinical/pathological responses to dostarlimab in stage II/III Rectal CancerModerate
Finnegan et al. (2022) [24]MultipleMeta-analysisN/AN/AImpact of immunotherapy in resectable rectal cancerModerate
Abbott et al. (2023) [25]USAMultimodal therapy studyN/ApMMRThe role of dostarlimab in multimodal therapy for pMMR rectal CAModerate
Barret et al. (2019) [26]MultipleReal-world effectivenessN/AMSI-highReal-world effectiveness of dostarlimab in MSI-high rectal cancerModerate
Morrison et al. (2021) [27]USAProspective evaluationN/AdMMRProspective evaluation of dostarlimab in locally advanced dMMR RCModerate
Robbins et al. (2020) [28]USAFive-year review studyN/AN/ASafety and efficacy of dostarlimab in elderly rectal cancer patientsHigh
Turner et al. (2021) [29]USAComprehensive analysisN/AMSI-stableComprehensive analysis of dostarlimab and pembrolizumab in MSI-stable RCModerate
Moreno et al. (2022) [30]USALong-term survival studyN/AN/ALong-term survival and quality of life in RC patients treated with dostarlimabModerate
DOI: https://doi.org/10.2478/fco-2024-0023 | Journal eISSN: 1792-362X | Journal ISSN: 1792-345X
Language: English
Submitted on: May 10, 2025
Accepted on: Nov 6, 2025
Published on: Apr 1, 2026
In partnership with: Paradigm Publishing Services
Publication frequency: 2 issues per year

© 2026 V.K Singh, Jigar Haria, Ajay Kumar, Prithpal Singh Matreja, published by Helenic Society of Medical Oncology
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

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