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RTOG 9705, A Phase II Trial of Postoperative Adjuvant Paclitaxel/Carboplatin and Thoracic Radiotherapy in Resected Stage II and IIIA Non-Small Cell Lung Cancer (NSCLC) Patients - Promising Long Term Survival Results

Reviewer: S. Jack Wei, MD
Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado: 20 de octubre del 2003

Presenter: Mary V. Graham
Presenter's Affiliation: Phelps County Regional Medical Center
Type of Session: Scientific

Background

The role of adjuvant chemotherapy in addition to radiotherapy (RT) for resected stage II and IIIA NSCLC patients is unclear. A previously published large randomized trial from ECOG showed a lack of benefit of the addition of cisplatin to RT. The results of RTOG 9705, a phase II trial of carboplatin and paclitaxel have previously been reported. The mature results of this trial are presented here.

Materials and Methods

• A Phase II trial of NSCLC patients undergoing resection with negative margins, pathologically stage II or IIIA was conducted.
• Carboplatin (AUC=5) and paclitaxel (135 mg/m2) every 3 wks was delivered with concurrent RT (50.4 Gy, 1.8 Gy/d with 10.8 Gy boost for nodal extracapsular extension or chest wall invasion)
• An additional 2 cycles of carboplatin (AUC=6) and paclitaxel (225 mg/m2) every 3 weeks was delivered following RT for a total of 4 cycles of chemotherapy.
• Results were analyzed for overall survival (OS), disease-free survival (DFS), and toxicity.

Results

• 87 patient were ultimately eligible for analysis.
• The majority of patients were <60 yrs (56%) and had good performance status (87% KPS 90-100).
• Median OS was 50.5 mo; the 3-yr OS was 61%.
• Median DFS was 35.6 mo; the 3-yr DFS was 50%.
• Brain mets were the first site of failure in 22% of patients, other metastatis were the first sites of failure in 17%.
• Grade 3/4 neutropenia and thrombocytopenia were seen in 34.1% and 6% of patients, respectively.
• Grade 3/4 esophagitis was seen in 16% of patients.
• Compared to the historical results of the ECOG trial of adjuvant cisplatin therapy for resected NSCLC, the median OS was 33.7 mo in the ECOG trial compared to 50.7 mo in the current trial (p=0.03).

Author's Conclusions

• The current trial shows improved OS and DFS compared to historic controls.
• There was a high rate of intracranial failures as the site of first failure.
• A phase III trial is warranted.

Clinical/Scientific Implications

The current trial shows promising results for adjuvant carboplatin/paclitaxel chemotherapy for completley resected stage II and IIIA NSCLC. The reason for the improved survival compared to the ECOG trial is unclear, although may be due to stage migration as the current trial was conducted after the ECOG trial. It may also be due to selection bias in the patient population. Nevertheless, the results of this study support the need for a phase III study comparing combined adjuvant chemotherapy and radiation with chemotherapy alone.

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