Lancet Glob Health: Low-cost oral rhythm chemotherapy to treat relapsed metastatic head and neck cancer.

Palliative care options for head and neck cancer patients recommended by the National Comprehensive Cancer Network (NCCN) are less applicable (less than 1-3%) in low- and middle-income countries (LMIC) for cost reasons.
previous Phase 2 study, head and neck cancer patients who received rhythmic chemotherapy had a better prognosis than those who received intravenous cisplatin, which is often used as the standard treatment for LMICs.
study is intended to confirm these findings.
study was conducted in an open-label, parallel grouping, non-disadvantaged, randomized Phase 3 trial conducted by the Oncology Department at the Tata Memorial Center of the Indian Institute.
recruited adult patients (ages 18-70) with relapsed or newly diagnosed head and neck squamous cell carcinoma who planned to receive palliative system therapy.
random groups (1:1) receive oral rhythm chemotherapy: methotrexate (15 mg/m2, 1/week) and celexib (200 mg, 2/day) until the disease progresses or has intosible side effects, or receives intravenous cisplatin (75 mg/m2, 1/3 weeks for a total of 6 sessions).
end point is the medium overall lifetime.
May 16, 2016 - January 17, 2020, 422 patients were randomly assigned: 213 to the oral rhythm chemotherapy group and 209 to the intravenous cisplatin group.
422 patients were all included in the intentional therapy analysis, and 418 patients (211 in the oral rhythm chemotherapy group and 207 in the intravenous cisplatin group) were included in the programme analysis.
the medium follow-up of
(overall survival of intentional treatment population) was 15.73 months, the medium total survival of oral rhythm chemotherapy group was 7.5 months (IQR4.6-12.6), while intravenous cisplatin group was not 6.1 months (3.2-9.6 months) (unedjusted risk of death ratio of 0.773 (95% CI 0.615-0.97, p=0.026) ).
in the programme analysis group, the medium total survival of the oral rhythm chemotherapy group was 7.5 months (4.7 to 12.8) and that of the intravenous cisplatin group was 6.1 months (3. 4 to 9.6) (unedjusted death HR is 0.775 (95% CI 0.616 to 0.974, p=0.029) ).
37 (19%) of the 196 patients in the oral rhythm chemotherapy group had a level 3 adverse event, while 61 people (30%) in the intravenous cisplatin group had an adverse reaction of magnitude 3 (p-0.01).
, in palliative care for head and neck cancer, oral rhythm chemotherapy was no less effective than intravenous cisplatin and had fewer adverse events.
, oral rhythm chemotherapy may become a new alternative if the current NCCN approved palliative care is not available.
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