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Q. Chen
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P2.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 213)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.03-015 - A Phase II Trial of Individual Trimodality Treatment in Patients with Stage IIIA (N2) Non-Small Cell Lung Cancer: The ZTOG 1202 Study (ID 2805)
09:30 - 09:30 | Author(s): Q. Chen
- Abstract
Background:
Currently, optimal management of clinical stage IIIA (N2) non-small cell lung cancer (NSCLC) is still controversial. We investigated the efficacy and toxicity of individual trimodality treatment using concurrent chemoradiotherapy as a neoadjuvant treatment followed by surgery in patients with stage IIIA (N2) NSCLC. This study is registered with ClinicalTrials.gov, number NCT01926483).
Methods:
Patients with potentially resectable locally advanced stage IIIA (N2) NSCLC received surgery and individual concurrent induction chemotherapy Docetaxel/Cisplatin or Pemetrexed/Cisplatin (Patients received individual chemotherapy regimens depending on the different pathological types: squamous cell carcinoma: Docetaxel 60mg/m[2] d1, Cisplatines 75mg/m[2] d1, repeated every 3 weeks for 2 cycles; non-squamous cell carcinoma: Pemetrexed 500mg/m[2] d1, Cisplatin 75mg/m[2] d1, repeated every 3 weeks for 2 cycles.) plus radiotherapy (46 Gy/23 fractions, 5 days per week) (Fig.1). Primary endpoint was pathological complete remission rate in the mediastinal lymph nodes and we aimed at a rate >47%. Secondary endpoint was a near pathologic complete response (pnCR) (Near pCR: near pathological complete response means only original site exist a small amount of cancer cells, without lymph node metastasis) rate and we aimed for >33%. Figure 1
Results:
Twenty two patients were included in analyses (12 patients with squamous cell carcinoma treated with Docetaxel/Cisplatin, 10 patients with non-squamous cell carcinoma treated with Pemetrexed/Cisplatin ). Pathological complete remission rate in the mediastinal lymph nodes was achieved in 11 patients (50%) exceeded the goal per study design. The postinduction pathological findings by T and N category were recorded. The categories were 3 T~ 0~N~0~ (13.6% patients) and 6 T~near 0~N~0~ (27.3% patients). In our study, the prevalence of postoperative complications was low, which was probably due to the thoracoscopic approach that was employed. No treatment-related deaths were reported. Toxicities associated with induction chemoradiotherapy were similar in both regimens. Neutropenia and esophagitis were the main grade 3 or 4 toxicities (9 [40.9%] and 2 [9.1%], respectively). Other grade 2 or higher toxicities occurring in about 50% of patients included nausea, vomiting, and fatigue. Most side effects were grade 2 and well tolerated by supportive care.
Conclusion:
Individual concurrent chemoradiotherapy based on the pathological type as a neoadjuvant treatment (two cycles of Docetaxel/Cisplatin or Pemetrexed/Cisplatin with 46 Gy/23f of concurrent radiotherapy) followed by resection was safe and well tolerated in patients with stage IIIa (N2) NSCLC. It could improve the pathological complete remission rate in the mediastinal lymph nodes to the preset criterion of 50% and a pnCR rate of 40.9%.