Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial

Pubmed

Hypothesis:
Addition of external beam radiation after surgery in early stage endometrial cancer improves survival

Site:
Endometrium

Experimental arm:
Surgery followed by 46 Gy in 2 Gy daily fractions, 3 or 4 field technique (Fields: superior border at L5/S1)

Standard Arm:
Surgery alone

Eligibility Criteria

• TAH/BSO without routine LND with these criteria
  

  Invasion	Grade
  >50% (deep)	1
  any	2
  <50% superficial	3

• WHO score of 0-2
• Histologies allowed:
  • Endometrioid (also including adenocarcinoma with squamous features)
  • Adenocarcinoma not otherwise specified
  • Adenosquamous carcinoma
  • Papillary serous carcinoma
  • Clear-cell carcinoma

Primary Outcome:
Locoregional recurrence and overall survival

Results:

Outcome	EBRT	Observation	p-value
Locoregional Recurrences	4%	14%	SS
Overall Survival**	81%	84%	NS
Major Toxicity	25%	6%	SS

• 73% recurrences in the vagina. Rate of distal mets same ~7% each arm
• Prognostic Factors: Age >60, G3, IC predictive for LR; If 2 of 3 criteria, LR 23% vs. 4% (SS)

Conclusions:
Postoperative radiation improves locoregional control, but no survival benefit

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