Efficacy and tolerability of an induction chemotherapy regimen based on gemcitabine and cisplatin in children and adolescents with nasopharyngeal carcinoma. Preliminary results of the NPC-DGOI-2022 study

Эффективность и переносимость индукционного режима химиотерапии на основе гемцитабина и цисплатина у детей и подростков с назофарингеальной карциномой. Предварительные результаты исследования НФК-ДГОИ-2022
Rabaeva L.L. Zhukov N.V. Volkova A.R. Nurgaliev D.Zh. Grachev N.S.
2025 Graphica Ltd

Russian Journal of Pediatric Hematology and Oncology
2025 #12 Issue 2 20 - 30 pp.

Background. Despite the high effectiveness of modern treatment protocols for localized (stage I-IVa) nasopharyngeal carcinoma (NPC) in children, some patients (15-20 %) fail to achieve a cure, which leads to an extremely unfavorable prognosis due to the low effectiveness of subsequent therapy. The prognosis of patients with primary metastatic NPC (stage IVb), whose 5-year overall survival does not exceed 60 %, remains unfavorable. The toxicity of treatment (primarily severe mucositis) is also a problem due to the 5-fluorouracil (5-FU)-containing induction regimens used in children with NPC. At the same time, it has been shown that the use of alternative gemcitabine-based induction therapy regimens and the introduction of new drugs (immune checkpoint inhibitors, capecitabine) into the therapy program leads to an increase in the effectiveness and safety of NPC treatment in adults. In order to improve the results of treatment of NPC in children, we have developed the original study NPC-DGOI-2022, the main difference between which and existing NPC treatment regimens in pediatric practice is the use of gemcitabine-containing induction regimen with or without the addition of pembrolizumab, depending on the risk group. The aim of the study - to evaluate the efficacy and tolerability of induction therapy according to the NPC-DGOI-2022 protocol (gemcitabine + cisplatin +/- pembrolizumab regimen). Materials and methods. The pilot analysis included 14 previously untreated patients with morphologically confirmed NPC who were treated according to the NPC-DGOI-2022 protocol in pediatric oncological institutions in Russia and the Republic of Kazakhstan from November 2022 to August 2024 (21 months). The average age of patients at the time of diagnosis was 14.4 years (range - 12-17 years); the ratio of boys and girls was 10:4. Among the 14 patients, 3 had stage II of the disease, 6 had stage III, 3 had IVa, and 2 had IVb. According to the protocol, patients in the standard and high-risk groups (stage II-IVa, n = 12) received induction therapy with gemcitabine and cisplatin, patients from the very high-risk group (IVb with metastatic foci that cannot be fully irradiated, n = 2) additionally received pembrolizumab. The objective response after completion of the induction stage of treatment was assessed according to RECIST 1.1, and the toxicity assessment was carried out according to CTCAE 5.0. Results. All patients completed the induction therapy stage on schedule and without dose reduction. After completion of the induction stage of treatment, a complete response was found in 3/14 (21 %) patients, a partial response in 11/14 (79 %). The only adverse events of ≥ III degrees of severity observed during induction therapy were leukopenia and neutropenia. Conclusion. The induction chemotherapy regimen containing gemcitabine and cisplatin with or without the addition of pembrolizumab has been shown to be well tolerated and to have high immediate efficacy, at least comparable to 5-FU-containing induction regimens, in children with NPC. However, a multicenter study is needed to reach the planned number of patients included for the final analysis.

children and adolescents , induction therapy , nasopharyngeal carcinoma

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Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, Ministry of Health of Russia, 1 Samory Mashela St., Moscow, 117997, Russian Federation
Republican Childrens Clinical Hospital, Ministry of Health of the Republic of Tatarstan, 140 Orenburgsky tract St., Republic of Tatarstan, Kazan, 420138, Russian Federation
Astana Medical University, 49a Beibitshilik St., Astana, 010000, Kazakhstan

Dmitry Rogachev National Medical Research Center of Pediatric Hematology
Republican Childrens Clinical Hospital
Astana Medical University

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