Molecular Markers for Long-term Survival in Stage IIIA (N2) NSCLC Patients

17036 Background: To investigate the role of weekly chemotherapy with paclitaxel/cisplatin and concurrent thoracic radiation (RT) as neoadjuvant therapy before surgical resection for patients with N2-IIIA NSCLC. Methods: Patients with pathologically proven N2 (pN2) and operable stage IIIA NSCLC were eligible. Six weekly chemotherapy with paclitaxel (50 mg/m2)/cisplatin (20 mg/m2) was given with concurrent thoracic RT (1.8 Gy/fraction once a day, 45 Gy) during 5 weeks. Chest CT, whole body PET were checked before and 3 weeks after chemoradiation. For the patients without clearing pN2 nodes or with pT3 after surgical resection, boost RT (20 Gy) was given. Results: From Jan. 2002 to Nov. 2005, 38 patients were enrolled. Median follow-up time was 20 months: gender (male: female, 30:8,), age (median 56, 42–67). Of them, 31 patients underwent surgical resection. Three patients showed brain metastasis during chmoradiation. Two patients refused surgical resection after chemoradiation. One patient showed severe radiation pneumonitis and was not fit for the operation. One patient showed lung to lung metastases before surgical resection. Of the 31 patients who underwent surgical resection, 14 (45.2%) showed pN0–1, and 7 (22.6%) showed pathologic complete remission (CR). Three year overall survival rate of all patients was 37.7% (median 35.9 months) and 3 year progression free survival was 34.2% (median 18 months). In univariate analysis, clearing N2 node and pathologic CR after surgery were the factors that could predict long-term survival. And the 2nd PET after chemoradiaiton could not expect clearing N2 nodes after surgical resection: sensitivity 44%, specificity 46%. As toxicities of WTP, hypersensivity reaction to paclitaxel and pneumonia with neutropenia were noted in 1 patient each. Severe radiation pneumonits was noted in 4 (of them 3 were given 65 Gy). Conclusions: WTP followed by surgical resection for N2-stage IIIA NSCLC was feasible. Clearing N2 nodes or pathologic CR after surgical resection were the factors of long-term survival. The usefulness of 2nd PET to expect the clearing N2 nodes was not adequate. No significant financial relationships to disclose.

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Randomized trial of amifostine in locally advanced non-small cell lung cancer (NSCLC) patients receiving chemotherapy and hyperfractionated radiation (HRT): Long-term survival results of Radiation Therapy Oncology Group (RTOG) 9801

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.7529 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 7529-7529

Author(s):

B. Movsas ◽

J. Moughan ◽

C. Langer ◽

M. Werner-Wasik ◽

N. Nicolaou ◽

...

Keyword(s):

Locally Advanced ◽

Radiation Therapy Oncology Group ◽

Disease Free Survival ◽

Rank Test ◽

Term Survival ◽

Long Term Survival ◽

Patient Reported ◽

Nsclc Patients

7529 Purpose: This analysis was conducted to address the potential antitumor effect of amifostine (AM) in NSCLC patients enrolled on RTOG-9801. The long-term survival results of RTOG-9801 are presented here. Methods: 243 patients (pts) with stage II/IIIAB NSCLC received induction paclitaxel (P) 225 mg/m2IV days 1, 22 and carboplatin (C) AUC 6 days 1, 22 and then concurrent weekly P (50 mg/m2) and C (AUC 2) and HRT (69.6 Gy at 1.2 Gy BID). Pts were randomly assigned to AM 500 mg IV 4x/week or no-AM during chemoradiation. Treatment differences for overall and disease-free survival (OS & DFS) were analyzed with the log-rank test; Gray's test was used for time to progression (TTP). Results: 118 pts were randomly assigned to receive AM and 121 to no-AM (4 pts were ineligible). The median follow-up for pts still alive is 52.3 months (mo) for the AM-arm and 58.3 mo for the no-AM arm (16.6 vs 17.9 for all pts). There are no significant differences in OS, DFS or TTP between arms. The median survival, 3-yr, and 5-yr OS are 17.1 mo, 27% and 17% (AM-arm) vs 18.4 mo, 28% and 16% (no-AM arm) (p=0.97). Grade 3/4/5 late-RT toxicities are similar (11%/3%/2% AM-arm vs 14%/4%/2% no-AM arm). Conclusion: While an earlier publication reported that amifostine did not reduce objective measures of severe esophagitis in RTOG-9801, patient-reported outcome analyses suggested a possible advantage to AM with decreased pain and swallowing symptoms (J Clin Oncol 23:2145–2154, 2005). This long-term follow-up analysis on survival shows no evidence of tumor radioprotection due to amifostine. The promising 5-yr OS suggests that induction paclitaxel/carboplatin (P/C) followed by concurrent RT and weekly low-dose P/C is comparable to other regimens using cisplatin doublets at higher dosages every 3–4 weeks. Research supported by NCI and Medimmune Oncology. No significant financial relationships to disclose.

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