Table 4.
Surgical Outcomes After Neoadjuvant Immunotherapy in Phase 2 Studies
| Study ID Trial Name |
No. of Surgical Pts | Neoadjuvant tx | Type of Surgery | Surgical Approach | Resection Rate | Mortality | Surgical Complications/Morbidity | Bleeding Requiring Transfusion | Pneumonitis | Pneumonia | Bronchopleural Fistula | Prolonged Air Leak | Resp Failure | Median LOS (d) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Immunotherapy as mono therapy or dual therapy | ||||||||||||||
|
NCT02994576 PRINCEPS12 |
30 | Atezolizumab | Pneumonectomy: 2/30 (7%) Lobectomy: 28/20 (93%) |
NR | R0: 29/30 (97%) R1: 1/30 (3%) |
0 | 7/30 (23%) (grade ≤3) |
NR | 0 | 0 | 0 | 1/30 (3%) | 0 | NR |
|
NCT01820754 TOP120122 |
13 | Ipilimumab | Pneumonectomy: 1/13 (8%) Lobectomy: 10/13 (77%) Bilobectomy: 1/13 (8%) Wedge resection: 1/13 (8%) |
Open: 1/13 (8%) VATS: 9/13 (69%) Converted VATS to open: 3/13 (23%) |
R0: 13/13 (100%) | 0 | 9/13 (69%) | 2/13 (15%) | 0 | 0 | 0 | 2/13 (15%) | 0 | 5 (IQR: 4–6) |
|
NCT02259621 CheckMate 15941 |
20 | Nivolumab | Lobectomy: 15/20 (75%) Pneumonectomy: 2/20 (10%) Bilobectomy: 1/20 (5%) Wedge resection: 1/20 (5%) Sleeve lobectomy: 1/20 (5%) |
Thoracotomy: 14/20 (70%) Thoracoscopy: 3/20 (14%) RATS: 3/20 (14%) Conversion rate: 7/13 (54%) |
NR | 0 | 10/20 (50%) | 0 | 0 | 1/20 (5%) | 0 | 1/20 (5%) | 0 | 4 (range: 2–17) |
|
NCT03158129 NEOSTAR13,33 |
37 | Nivolumab | Lobectomy: 30/37 (81%) Sleeve lobectomy: 2/37 (5%) Bilobectomy: 1/37 (2%) Pneumonectomy: 2/37 (5%) Segmentectomy: 1/37 (2%) Wedge resection: 1/37 (2%) |
Thoracotomy: 27/37 (73%) VATS: 7/37 (19%) RATS: 3/37 (8%) Conversion: 2/12 (17%) |
R0: 37/37 (100%) | 0 | 13/21 (62%) | 0 | 1/21 (5%) | 1/21 (5%) | 1/21 (5%) | 5/21 (24%) | 0 | 4 (range: 1–18) |
| Nivolumab + ipilimumab | 1/21 (5%; pneumonitis; BPF/ ARDS) | 6/16 (38%) | 0 | 1/16 (6%) | 1/16 (6%) | 0 | 3/16 (19%) | 0 | ||||||
| ChiCTR-OIC-1701372623 | 37 | Sintilimab | Lobectomy: 24/37 (65%) Pneumonectomy: 13/37 (35%) |
NR | R0: 36/37 (97%) R2: 1/37 (3%) |
30-d: 1/37 (3%; immune-related pneumonia) | 4/37 (11%) | NR | 0 | 1/37 (3%) | 0 | 0 | 0 | NR |
| Combination immunotherapy plus chemotherapy | ||||||||||||||
|
NCT02716038 Columbia7 |
29 | Atezolizumab + carboplatin + nab-paclitaxel | Lobectomy: 73% Bilobectomy: 15% Pneumonectomy: 12% |
VATS: 12/26 (46%) Thoracotomy: 14/26 (54%) |
R0: 26/29 (87%) | 30-d: 1/29 (3%; pneumonia and respiratory failure) | 6/29 (21%); none related to neoadjuvant treatment | 2/29 (7%) | 0 | 1/29 (3%; resulted in death) | 0 | 0 | 1/29 (3%; resulted in death) | 4 (IQR: 3–6) |
|
NCT02572843 SAKK 16/1450 |
55 | Durvalumab + cisplatin + docetaxel | Pneumonectomy: 5/55 (9%) Lobectomy: 43/55 (78%) Bilobectomy: 5/55 (13%) |
NR | R0: 50/55 (91%) R1: 3/55 (6%) R2: 2/55 (4%) |
30-d: 1/55 (2%) | Grade 3–5: 17/55 (31%) | NR | NR | NR | NR | NR | NR | NR |
|
NCT03081689 NADIM51 |
41 | Nivolumab + paclitaxel + carboplatin | Lobectomy: 38/41 (93%) Pneumonectomy: 3/41 (7%) |
NR | R0: 41/41 (100%) | 0 | 12/41 (29%) | 0 | 0 | 0 | Respiratory infection: 5/41 (12%) |
2/41 (5%) | 0 | NR |
ARDS, acute respiratory distress syndrome; BPF, bronchopleural fistula; IQR, interquartile range; LOS, length of (hospital) stay; NR, not reported; Pt, patient; RATS, robotic-assisted thoracoscopic surgery; tx, treatment; VATS, video-assisted thoracoscopic surgery.