Table 62–4, 20, 21.
Phase II Trials for the Treatment of Superior Sulcus NonSmall Cell Lung Cancer 2001-Present
|
1st Author/Insti tution or Group + Trial #/Publ Year |
Number of Patients (after exclusio ns) |
Inclusion Criteria |
Chemother apy Regimen |
Radiation Therapy Dose |
Grade 3 + 4 Toxicity |
Inductio n Deaths |
Inductio n Disease Progressi on |
Number Surgical ly Resecte d |
Number Completel y Resected (R0) |
pCR + Min Residual = Total |
Surgical Mortalit y |
Number Surgically Rx w Consolida tion Thx |
Planned Consolida tion Regimen |
Consolidatio n Deaths, Grade 3 + 4 Toxicity |
Number Surgically Rx Completin g Consolida tion that started it |
Survival |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rusch/SWOG 9416/2001, 20072,3 | 110 | Histologically or Cytologically proven, cT3-4, cN0-1 NSCLC, Mediastinoscopy All, No Wedge Allowed, PS≤2, cT3 71%, cN0 not reported | CDDP/VP-16 × 2 | Concurrent 45 Gy to include ipsilateral supraclavicular nodes, not mediastinum or hilum | Combination not reported | 3(2.7%) | 9/110(8.2%) | 88(80%) | 83(94%) | 32/88(36 %) + 29/88(33 %)=61/8 8(69%) | 2/88(2.3%) | 59/88(67 %) | CDDP/VP-16 × 2 | Complications during this Phase Not Reported | 49/59(83 %) | MST 33 mos all 110 patients, 94 mos if R0; 2- yr OS 55%, 5-yr OS 44%, 54% for R0, if pCR+Min Res 45%; pCR better survival |
| Marra/University of Essen/200721 | 31 | Histologically or Cytologically proven cT3-4, cN0-3 NSCLC, Mediastinoscopy All, PS≤2, Wedge Allowed cT3 81%, cN0 67.7% | CDDP/VP-16 × 3 in first 22, remaining 9 PTX instead of VP-16 during Rad Rx | At 10th wk, Concurrent 45 Gy (1.5 BID) including ipsilateral supraclavicular nodes, if cN2-3 target mediastinum, IIIB treated w PCI | 32%, not graded according to CTCAE | 0 | Not Reported | 29(94%) | 27/29(93.5%) on final analysis | 13/29 (45%)+7/ 29 (24%)=2 0/29(69 %) | 2/29(7 %) | Not Applicable | Not Applicable | Not Applicable | Not Applicable | MST 54 mos, 2-yr OS 74%, 5-yr DFS 52%, 5-yr OS 46% |
| Kunitoh/JCOG 9806/20084 | 75 | Histologically or Cytologically proven cT3-4, cN0-1 NSCLC, CT criteria node < 1 cm, Mediastinoscopy to R/O Disease, No Wedge Allowed, ipsilateral N3 included, PS≤1, cT3 74%, cN0 78% | MMC/VND/CDDP × 2 | Concurrent 45 Gy (splitcourse 1-wk) includes ipsilateral supraclavicular nodes, not mediastinum or hilum | Combination not reported | 1(1.3%) | 5/75 (6.7%) | 57/75 (76%) | 51/57 (89%) | 12/57(21 %), min residual disease not reported | 2/57(3.5%) | Boost Radiotherapy to 66.6 Gy if not R0, no consolidation chemothx | Not Applicable | Not Applicable | Not Applicable | DFS 28 mos, OS not reached, DFS 3-yr 49%, 5-yr 45%; OS 3-yr 61%; 5-yr 56%; R0 patients OS 5-yr 70% |
| Gomez/MD Anderson/2 01220 | 32 | Histological cT3-4, cN0-2 NSCLC, No Wedge Allowed, PS≤70%, cT3 81%, cN0 84.5% | Postoperative CDDP/VP-16 × 5, first 2 cycles concurrent w Rad Rx, included hilum & mediastinum | Concurrent Postoperative 60 Gy (1.2 gy Fractions BID); if margin neg, 64.8 Gy if margin pos, 11 Rx Prophylactic PCI | NA | NA | NA | 32(100 %) | 23(72%) | NA | 0% | NA | Adjuvant Provided, Not Consolidation | No Deaths, Dysphagia 10, Pneumonitis 1, Lung Fibrosis 1, Leukopenia 1, Granulocytopenia 1 | 78% Complete d Protocol | DFS 2-yr 49%, 5-yr 45%, 10-yr 45%; OS 2-yr 72%, 5-yr 50%, 10-yr 45% |
| Kernstine/SWOG 0220/2012 | 44 | Histologically or Cytologically proven NSCLC cT3-4, N0-1 Negative mediastinum confirmed by mediastinoscopy or Negative PET+CT, PS ≤2, No Wedge Allowed, cT3 73%, cN0 89% | CDDP/VP-16 × 2 | Concurrent 45 Gy to include the ipsilateral supraclavicular area, Hilum & Mediastinum not mandated | 18 (41%) | 1 (2%) from neutropenic infection | 5/44 (11%) | 29 (66%) | 28(97%) | 8/29 (28%) + 13/29 (45%)= 21/29 (72%) | 2/29 (7%), Both from ARDS | 22/29(76 %) | Dox × 3 | 0%, 13/22(59%) | 20/22(91 %) | 1-yr PFS 76%, 3-yr PFS 56%, OS 61%. Median OS 4 yrs |
ARDS-Adult Respiratory Distress Syndrome; BID-Twice Daily; CDDP-Cisplatin; CTCAE-Common Terminology Criteria for Adverse Events; CT-Computed Tomogram; DFS-Disease Free Survival; Dox-Docetaxel; Gy-Gray radiation dose; JCOG-Japan Clinical Oncology Mitomycin C; mos-months; MST-median survival time; OS-Overall Survival; pCR-Pathologically Complete Response, no viable tumor in the resected specimen; PET-Positron Emission Tomography; PS-Performance Status (Zubrod); PTX-Paclitaxel; R0-complete clear of disease; Rad Rx-Radiation Therapy; SWOG-Southwest Oncology Group; VND-Vindesine; VP-16-Etoposide; Wk-Week