NATCH trial finds no benefit for chemo Rx plus surgery

SAN FRANCISCO-Chemotherapy before surgery for early-stage, non-small-cell lung cancer led to moderately higher survival rates than surgery alone, but not enough to reach statistical significance, according to follow-up analysis of the European NATCH trial. However, the researchers did note that patients were more likely to finish the prescribed chemotherapy course when treatment was given preoperatively.

NATCH (Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer) is the only study to date prospectively designed to compare two distinct experimental arms with surgery alone, which is the current standard of care in early disease. The primary endpoint in the NATCH trial was five-year disease-free survival (DFS).

“As you know, in patients with clinical stage I and II disease, the five-year survival rate is less than 50%,” Enriqueta Felip, MD, said at the 2009 World Conference on Lung Cancer. Dr. Felip is from Vall d’Hebron University Hospital in Barcelona, Spain; the trial was conducted by the Spanish Lung Cancer Group.

Results of the study showed that five-year DFS was 34% for 212 patients assigned to surgery alone, 37% for 211 patients in the adjuvant chemotherapy arm, and 38% among the 201 patients who underwent preoperative chemotherapy. The findings suggested that preoperative chemotherapy had a non-significant trend toward improved five-year DFS when compared with surgery alone, she said (abstract PRS.3).

In terms of overall survival (OS), there was a 44% five-year OS in the surgeryalone arm, 45.5% in the adjuvant therapy arm, and 46.6% in the preoperative chemotherapy arm. Dr. Felip pointed out that 90% of the patients who received preoperative chemotherapy completed at least three cycles with carboplatin and paclitaxel, while only 61% of the patients who were assigned to postoperative chemotherapy completed three cycles.

Chemotherapy was well tolerated in both arms, Dr. Felip said, although there was improved compliance when chemotherapy was given preoperatively. In the adjuvant arm, postsurgical complications were the main reasons that some patients did not undergo chemotherapy. Additional reasons included postoperative mortality, other histologies on the final pathologic report, and patient refusal to have more treatment after surgical resection.