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HPV, p16 expression associated with significant improvement in response, OS in recurrent, metastatic SCCHN
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CHICAGO — The presence of HPV and tumor p16 status were associated with significant improvements in objective response and OS among patients with recurrent or metastatic squamous cell carcinoma of the head and neck, according to study results presented at the ASCO Annual Meeting.
The researchers also examined excision repair cross-complementation group 1 (ERCC1) tumor expression, and ERCC1 low status was associated with a trend toward better OS, researchers said.
More than 45,000 new cases of SCCHN are diagnosed in the United States each year. Patients with recurrent or metastatic disease often are treated with cisplatin-based chemotherapy, but prognosis is poor, according to background information provided by researchers.
“We know from the trials of locally advanced disease that you can have improved survival with HPV-positive disease. Seeing that it still holds true in a metastatic population is valuable,” lead researcher Ranee Mehra, MD, an attending physician on the medical oncology staff at Fox Chase Cancer Center in Philadelphia, told HemOnc Today.
Mehra and colleagues obtained archival baseline specimens from patients enrolled in two Eastern Cooperative Oncology Group trials: E1395, a phase 3 trial that compared cisplatin plus paclitaxel with cisplatin plus 5-fluorouracil; and E3301, a phase 2 trial of docetaxel/irinotecan.
Mehra and colleagues used Fisher’s exact test and log-rank test to compare categorical variables and survival. They used stratified logistic regression to estimate odds ratio and Cox regression model to estimate hazard ratio, and they adjusted for potential confounding factors.
The researchers reported evaluable tissue from 65 tumors for HPV, 66 for tumor p16 status and 30 for ERCC1 expression. Tumor p16 status was defined as positive if immunohistochemical staining for p16 was strong and present in more than 80% of tumor cells.
Of the 65 tissue samples evaluable for HPV, 11 were HPV-positive and 12 were p16-positive.
Researchers reported higher objective response rates for HPV-positive tumors than HPV-negative tumors (54.5% vs. 18.5%; P=.02). The results revealed HPV-positive status was associated with improved OS (HR=2.66; 95% CI, 1.16-6.09) and improved PFS (HR=1.63; 95% CI, .80-3.32).
Response rates were higher for p16-positive tumors than p16-negative tumors (50% vs. 18.5%; P=.048). The results showed p16-positive tumor status was associated with improved OS (HR=2.27; 95% CI, 1.04-4.98) and PFS (HR=1.45; 95% CI, 0.73-2.88).
Sixteen tumors were classified as ERCC1 high and fourteen were classified as ERCC1 low. Researchers reported higher response rates among patients with ERCC1 low tumors (43% vs. 37.5%). Results suggested a trend toward improved OS (HR=2.04; 95% CI, 0.78-5.34) for patients with ERCC1 low tumors.
Among patients treated with cisplatin plus 5-fluorouracil, the response rate was 50% for ERCC1 low tumors and 25% for ERCC1 high tumors. Among patients treated with cisplatin plus paclitaxel, the response rate was 37.5% for ERCC1 low tumors and 50% for ERCC1 high tumors.
The results suggest the effect of ERCC1 may be different for taxane vs. non-taxane regimens, the researchers wrote.
The study was limited because it was based on a retrospective analysis across two trials, its small sample size limited its statistical power, and the fact archival tissue was used rather than fresh biopsies. However, the results provide valuable information that should be considered when future trials of patients with recurrent or metastatic SCCHN are designed, Mehra said.
“In most recurrent, metastatic trials, everyone is grouped together,” Mehra said. “Going forward, perhaps we should be stratifying by HPV status or p16 status, because that could impact the results of the study.”
For more information:
Mehra R. Abstract #6006. Presented at: ASCO Annual Meeting; May 31-June 4, 2013; Chicago.
Disclosure: The researchers report no relevant financial disclosures.