Oct 30, 2024

Public workspaceTreatment outcome of gemcitabine and cisplatin induction followed by concurrent chemoradiotherapy for stage III-IVA nasopharyngeal carcinoma: A retrospective study

DOI
dx.doi.org/10.17504/protocols.io.eq2ly6z9qgx9/v1
  • Son Nguyen Viet1
  • 1NgheAn Oncology Hospital
Son Nguyen Viet
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DOI: dx.doi.org/10.17504/protocols.io.eq2ly6z9qgx9/v1
Protocol Citation: Son Nguyen Viet 2024. Treatment outcome of gemcitabine and cisplatin induction followed by concurrent chemoradiotherapy for stage III-IVA nasopharyngeal carcinoma: A retrospective study. protocols.io https://dx.doi.org/10.17504/protocols.io.eq2ly6z9qgx9/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License,  which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: In development
We are still developing and optimizing this protocol
Created: October 25, 2024
Last Modified: October 30, 2024
Protocol Integer ID: 110895
Keywords: Nasopharyngeal carcinoma, chemoradiotherapy, Vietnam National Cancer Hospital, induction chemotherapy, disease-free survival, gemcitabine and cisplatin
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Abstract

BackgroundCombining induction chemotherapy with concurrent chemoradiotherapy is becoming increasingly popular for treating stage III-IVA nasopharyngeal cancer (NPC), especially in patients with Epstein-Barr virus (EBV)-associated disorders. The objective of this study is to assess the efficacy of this therapy regimen in terms of treatment response and disease control.

Method

This retrospective descriptive study analyzed 81 patients with stage III-IVA nasopharyngeal cancer (excluding T3N0M0) who underwent gemcitabine and cisplatin induction chemotherapy, followed by concurrent chemoradiotherapy at the Vietnam National Cancer Hospital. Data for the study were collected between 03/06/2021 and 03/06/2024. The study also involved a longitudinal follow-up of the patients. The primary endpoint was disease-free survival (DFS), with secondary outcomes assessing factors influencing DFS and treatment-related toxicity.

Results

During the initial 3-month period, 76 out of 81 patients achieved a complete response (CR), whereas 5 out of 81 patients achieved a partial response. The duration of the follow-up period was 18.7 ± 5.3 months, and the rate of 2-year disease-free survival (DFS) was 77.6%. The disease-free survival (DFS) was influenced by patient-related variables including age group, N stage, disease stage, and treatment interruptions. The toxicity observed in grade 3 were neutropenia (17.3%) and mucositis (32.1%), whereas grade 4 toxic effect was characterized by nausea (2.4%). 2.6% of patients experienced Grade I and II delayed toxic effects, as well as Grade III anorexia.

Conclusion

The combination of Gemcitabine and Cisplatin as an initial treatment, followed by chemoradiotherapy, demonstrated a significant rate of positive response, effectively controlling the disease with tolerable consequences. Additional investigation is required to ascertain the long-term effectiveness and delayed adverse effects.
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Guidelines
  • Patient Selection Criteria: Ensure that only patients meeting the inclusion criteria are enrolled. Obtain informed consent after explaining all risks, benefits, and potential outcomes of the treatment.
  • Chemotherapy Administration: Adhere to the prescribed dosages for gemcitabine and cisplatin. Monitor patients closely for toxicity or adverse reactions during each cycle.
  • Radiation Safety: During concurrent chemoradiotherapy, ensure all radiation safety protocols are followed to prevent unnec
Materials
Method
This study is a retrospective descriptive investigation that involves longitudinal follow-up from 03/06/2021 to 03/06/2024. It includes a total of 81 patients who were treated at the Vietnam National Cancer Hospital. The eligibility requirements are as follows: a) confirmation of NPC through pathological diagnosis, b) classification as stage III or IVA according to the AJCC 8th edition, c) undergoing treatment with Gemcitabine and Cisplatin induction chemotherapy followed by concurrent chemoradiotherapy, d) having an ECOG performance status score of 0-1, and e) possessing accessible patient data. The exclusion criteria include a) T3N0M0 stage, b) secondary cancers, c) chronic disorders such as heart failure or renal failure, d) prior treatment of the nasopharynx and/or neck region with radiotherapy, chemotherapy, or surgery, and e) pregnancy.
All patients at Vietnam National Cancer Hospital received the same treatment protocol. We documented the patient's attributes and their responses to therapy, and we monitored the occurrence of relapse, advancement, metastasis, the period without disease (disease-free survival), and harmful effects through follow-up phone calls and subsequent examinations. The data were accessed and analyzed by the authors for research purposes from July 1, 2024, to September 1, 2024.

Endpoints

The primary endpoint is disease-free survival (DFS) that refers to the period following the completion of initial cancer therapy, during which the patient is alive and free from any indications or symptoms of the cancer. Secondary endpoints encompass variables influencing DFS and adverse consequences.

Statistical analysis

Data were analyzed using SPSS version 20.0, employing the following methods:
  • Descriptive statistics: Mean, standard deviation, maximum, and minimum values.
  • Chi-square (χ²) test: 95% confidence interval, p < 0.05.
  • Kaplan-Meier method: Evaluating disease-free survival (DFS) duration, with group comparisons using the Log-rank test (p < 0.05).
Safety warnings
  • Toxicity Risk: The combination of gemcitabine and cisplatin carries a risk of severe toxicity. Immediate medical attention is required if patients exhibit signs of serious toxicity, such as renal impairment or severe myelosuppression.
  • Radiation Exposure: Ensure strict adherence to radiation protocols to prevent overexposure, which can lead to long-term health risks for b
  • Adverse Effects: Closely monitor patients for severe side effects, including nausea, vomiting, neutropenia, or neuropathy. If side effects become intolerable, treatment may need to be paused or adjusted.
  • Early Termination: If a patient develops severe contraindications or life-threatening side effects, early termination of the treatment protocol is advised to prevent further harm.
Ethics statement
Ethics Statement          
This study was approved by the Ethics Committee in Biomedical Research of Hanoi Medical University (IRB – VN01001; IRB00003121). Oral informed consent was obtained from all patients for data collection and usage. Written consent could not be obtained due to the retrospective nature of the study, where patients had already completed their treatment. The Ethics Committee approved the use of oral consent in this context. Oral consent was documented by recording each patient's agreement in their medical records at the Vietnam National Cancer Hospital, following the ethical guidelines established by the Institutional Review Board.
Before start
  • Medical History: Review the patient’s medical history to assess suitability for chemotherapy and radiation.
  • Physical Examination: Perform a thorough examination to evaluate overall health status.
  • Laboratory Tests: Conduct necessary tests (e.g., blood work, organ function tests) to ensure the patient is fit for treatment.
Treatment outcome of gemcitabine and cisplatin induction followed by concurrent chemoradiotherapy for stage III-IVA nasopharyngeal carcinoma: A retrospective study
Treatment outcome of gemcitabine and cisplatin induction followed by concurrent chemoradiotherapy for stage III-IVA nasopharyngeal carcinoma: A retrospective study

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