The investigators made a similar conclusion: “Addition of P to EOC chemotherapy was associated with worsening of OS in an unselected advanced OGA population, which may be due, in part, to lowered doses of O and C in the mEOC plus P regimen.”

Another abstract, presented in the head and neck cancer section by the West Japan Oncology Group, was entitled “Randomized phase III study of irinotecan (CPT-11) versus weekly paclitaxel (wPTX) for advanced gastric cancer (AGC) refractory to combination chemotherapy (CT) of fluoropyrimidine plus platinum (FP): WJOG4007 trial.”4 In this study, the investigators aimed to compare CPT-11 with wPTX in patients with advanced gastric cancer refractory to FP. To meet this aim, the investigators randomized patients with AGC refractory to the first‑line FP regimen to receive either CPT-11 (150mg/m2, every two weeks) or wPTX (80 mg/m2, days 1, 8, 15, every four weeks) until the primary end point of overall survival (OS) was reached; secondary end points included progression‑free survival (PFS), overall response rate (ORR), and more.


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Although there were differences in median OS between the two treatment arms, the difference was nonsignificant [8.4 months for CPT-11, 9.5 months for wPTX (HR 1.132; 95% CI, 0.86–1.49; P=0.38)]. As for the secondary end points, which were also nonsignificant, median PFS was 2.3 months for CPT-11 and 3.6 months for wPTX (HR 1.14; 95% CI, 0.88–1.49; P=0.33); ORR: 13.6% for CPT-11 and 20.9% for wPTX (P=0.20). Grade 3/4 adverse events included neutropenia (39.1% for CPT-11 vs 28.7% for wPTX), anemia (30.0% vs 21.3%), and others.

“The responses in this study were not different than other similar studies, but they were pretty good survival levels for second-line chemo,” commented Dr. Burtness. “And between the two regimens, treatment with paclitaxel seems to be the less toxic option and is probably the one that most people are using.”

The investigators concluded that this trial “did not demonstrate the superiority of CPT-11 over wPTX. Thus, wPTX can be adopted as a control arm of future phase 3 trials of second-line CT for AGC.”

Finally, Dr. Burtness was a coauthor on several studies presented at ASCO 2012, one of which was a trial-on-progress entitled “LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients.”5 The trial, which investigated the possibility of using adjuvant afatanib, an irreversible ErbB family blocker, which had previously demonstrated preclinical activity against all ErbB dimers including EGFR and HER2, to reduce the risk of recurrence in “high-risk patients who have no evidence of disease following platinum-based chemoradiation with or without neck dissection.”

Although no results were presented for this trial, a significant amount of information was reported about its clinical design. In this study, which is still recruiting, eligibility criteria are as follows: history of receiving chemoradiation (minimum 66 Gy) as well as concurrent cisplatin (≥200 mg/m2) or carboplatin (≥AUC 9) for the treatment of squamous cell cancer of the head and neck (SCCHN). The other eligibility requirement is adequate bone marrow, liver and kidney function. Excluded are those patients with base of tongue or tonsil cancer and ≤10 pack years of tobacco use, those with nasopharynx, sinus or salivary gland cancer, as well as those who have received prior therapy with investigational agents or EGFR inhibitors.