After surgery for advanced head and neck cancer, if the tumour has high-risk features, additional radiotherapy is usually given. This study showed that adding cisplatin to this radiotherapy raised the chance of being alive after 5 years from 40% to 53% and reduced the cancer coming back in the head and neck area, although severe short-term side effects were more common.
After surgery in high-risk patients; recommended by ESMO for microscopically positive margins (R1) and extranodal extension
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Cisplatin | 100 mg/m² (alternative: 40 mg/m² weekly) | IV | Days 1, 22 and 43 of radiotherapy |
| Radiotherapy | 66 Gy | External beam | Over 6.5 weeks |
Postoperative radiotherapy or chemoradiotherapy should start within 6 weeks after surgery [II, A]. Weekly cisplatin 40 mg/m² is a valid alternative in the postoperative setting [II, A].
High-risk stage III or IV squamous cell head and neck cancer after surgery (off-label use)
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Cisplatin | 100 mg/m² | Slow IV infusion | Days 1, 22 and 43 of radiotherapy |
| Radiotherapy | 66 Gy over 6.5 weeks |
Doses from the EORTC 22931 trial.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Postoperative radiotherapy 66 Gy over 6.5 weeks (irradiation of the preoperative primary tumour bed with a boost to areas at high risk of recurrence, using a cobalt-60 unit, a 4 to 6 MV linear accelerator or 6 to 12 MeV electrons) with cisplatin 100 mg/m² IV on days 1, 22 and 43 of radiotherapy (167 patients). The dose per fraction and the dose to low-risk areas are not stated in the abstract or the trial registration, and the full text of the paper was not available to us.
Postoperative radiotherapy with the same regimen: 66 Gy over 6.5 weeks (167 patients).
Source of the regimen details: Abstract of the paper (total radiotherapy dose and cisplatin) and ClinicalTrials.gov NCT00002555 (irradiated volume and equipment, eligibility criteria); radiotherapy fractionation is not stated in the available sources
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients aged 18 to 70 years with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, stage T3–T4 with any N (except T3N0 of the larynx with clear margins) or any T with N2–N3, without metastases (UICC), after surgery with curative intent and with at least one high-risk feature: pathologically positive surgical margins, perineural invasion, extranodal extension, involvement of level 4 or 5 nodes in tumours of the oral cavity or oropharynx, or vascular embolism. WHO performance status 0 to 2; creatinine at most 1.3 mg/dL and creatinine clearance more than 60 mL/min; randomisation within 25 days of surgery.
Primary endpoint: progression-free survival. Other endpoints: overall survival, locoregional recurrence and adverse events.
Severe (grade 3 or higher) adverse events were more frequent with combined treatment (41% versus 21%; P=0.001); the type of severe mucosal adverse events and the incidence of late adverse events were similar in the two groups.
EORTC 22931, together with RTOG 9501 (Cooper et al., N Engl J Med 2004), is the basis of postoperative chemoradiotherapy with cisplatin for high-risk patients. A pooled analysis of these two trials showed that the benefit is mainly in patients with positive surgical margins and/or extracapsular nodal extension, and these two features are today the main indication in guidelines for adding cisplatin to postoperative radiotherapy.
Old trial (before IMRT and HPV status determination); the high-risk criteria were broader than today's definitions; acute toxicity is substantial.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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