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A Tata Memorial trial ended a 50-year debate by showing that removing the neck lymph nodes at the first operation for early mouth cancer raises three-year survival from about two-thirds to four-fifths.
596 patients were enrolled and 500 analysed (245 elective, 255 therapeutic) with a median follow-up of 39 months. There were 81 recurrences and 50 deaths with elective dissection against 146 recurrences and 79 deaths with therapeutic dissection; 3-year overall survival was 80.0% versus 67.5% (hazard ratio 0.64; 95% CI 0.45-0.92; P=0.01) and disease-free survival 69.5% versus 45.9% (P<0.001), with adverse events in 6.6% versus 3.6%. Presented in the ASCO plenary and published in NEJM, it changed guidelines worldwide and showed that Indian centres, with their very large oral cancer volumes, can settle questions Western centres cannot.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
596 registered.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 3-year overall survivalprimary | Elective neck dissection | 245 | 80% | 0.64 (0.45 to 0.92) | 0.01 | link |
| Therapeutic neck dissection | 255 | 67.5% |
Shares Oral tongue and floor of mouth cancer, Buccal mucosa and gingivobuccal cancer (oral cancer in India), Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Head and neck squamous cell carcinoma.
Shares Oral tongue and floor of mouth cancer, Buccal mucosa and gingivobuccal cancer (oral cancer in India), Oral cavity cancer (mouth and tongue), Tata Memorial Centre.
Shares Oral tongue and floor of mouth cancer, Buccal mucosa and gingivobuccal cancer (oral cancer in India), Oral cavity cancer (mouth and tongue).
Shares Oral tongue and floor of mouth cancer, Buccal mucosa and gingivobuccal cancer (oral cancer in India), Oral cavity cancer (mouth and tongue), Sentinel lymph node biopsy.
Shares Buccal mucosa and gingivobuccal cancer (oral cancer in India), Oral cavity cancer (mouth and tongue).
Shares Buccal mucosa and gingivobuccal cancer (oral cancer in India), Oral cavity cancer (mouth and tongue), Head and neck squamous cell carcinoma.
Shares Buccal mucosa and gingivobuccal cancer (oral cancer in India), Tata Memorial Centre, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Head and neck squamous cell carcinoma.
Shares Buccal mucosa and gingivobuccal cancer (oral cancer in India), Tata Memorial Centre, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Overall survival (OS).