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Table 2 Outcomes from randomized trials with a surgical arm in stage III non-small cell lung cancer

From: A critical review of recent developments in radiotherapy for non-small cell lung cancer

Trial

Inclusion

Staging PET or PET/CT

Study question

RTa

Chemotherapy

N (randomized)

Answer

Treatment related mortality

5-year OS

EORTC 08941 [125]

Unresectable IIIA (N2)

Not mandatory

CT-S vs CT-RT

60–62.5 Gy to primary and involved mediastinum; 40–46 Gy to uninvolved mediastinum

Platinum-based with at least one other agent

332

No significant difference

4 % within 30 days of surgery

1 patient died of RP, timing NR

16 %

14 %

INT 0139b [126]

Potentially resectable IIIA (N2)

Not mandatory

CRT-S vs CRT

45 Gy in CRT-S arm

61 Gy in CRT arm

Cisplatin-etoposide

429 (396 eligible)

No significant difference

8 %

2 %

(No deaths during induction)

27 %

20 %

ESPATUEc [127]

Resectable IIIA (N2) and selected IIIB

97 %

CT-CRT-S vs CT-CRT-CRTboost

Both arms:

induction 45 Gy delivered as 1.5 Gy BID

In definitive CRT arm: risk-adapted CRTboost to 65–71 Gy

Induction: cisplatin-paclitaxel

Concurrent:

cisplatin-vinorelbine

161

No significant difference, but closed early and was under- powered with respect to the primary end-point of OS

6 % in surgical arm

3 % in definitive CRT arm

(2 additional patients died during induction)

44 %

40 %

SAKK 16/00 [128]

Resectable IIIA (N2)

Required (rate NR)

CT-RT-S vs CT-S

44 Gy (in 22 fractions over 3 weeks)

Cisplatin-docetaxel

232

No difference

0 % within 30 days of surgery

3 % within 30 days of surgery

40 %

34 %

  1. Courtesy of Prof. Rafal Dziadziuszko. Discussant ESMO 2014 Madrid. Modified to update subsequent publication
  2. CT induction chemotherapy, CRT concurrent chemoradiotherapy, RT radiotherapy; S surgery, CRTboost concurrent chemoradiotherapy boost, RP radiation pneumonitis, NR not reported, BID twice daily, OS overall survival
  3. aRT doses in standard fractionation unless otherwise indicated
  4. bIncreased disease-free survival in surgery arm (12.8 vs 10.5 months; p = 0.017); unplanned analysis showed longer median OS in lobectomy subgroup vs matched CRT subgroup (33.6 vs 21.7 months; p = 0.002)
  5. c246 enrolled (out of 500 planned). After induction treatment, patients with resectable tumors (n = 161, 65 %) randomized. In all 246 patients, 5 year OS 34 %