Rainer Fietkau, MD, on Pancreatic Cancer: Initial Trial Results on Sequential Chemotherapy and Chemoradiotherapy
2022 ASCO Annual Meeting
Rainer Fietkau, MD, of Germany’s University Hospital Erlangen, discusses phase III findings of the CONKO-007 trial, which examined the role of sequential chemotherapy and chemoradiotherapy administered to patients with nonresectable locally advanced pancreatic cancer following standard-of-care chemotherapy (Abstract 4008).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
So CONKO-007 study compared in a randomized Phase III trial the effect of chemoradiotherapy or chemotherapy following induction chemotherapy. We included the patients with nonresectable locally advanced pancreatic cancer. Following three months of induction therapy, restaging was performed and patients with new detected metastasis or insufficient dosage of chemotherapy were included. 525 patients were included. 366 patients were randomized.
Important, we had the following feature of the study. Nonresectability was confirmed a panel of five experienced surgeons. This was checked again following the whole therapy and surgery was recommended if an R0 resection seems to be possible. And, we succeeded, that in both arms about 36% of the patients were then treated with surgery. We think that this high number was due to the fact that surgery was often recommended in the second surgical evaluation.
The primary end point, the R0 resection, was evaluated in the 122 patients with resection. Following chemoradiotherapy, more R0 resections were possible. The rate of R1 resections was significantly lower. The OS rate of CRM negative tumor was significantly higher. Furthermore, we found significantly more complete remissions following chemoradiotherapy.
In a second analysis, for all randomized patients nearly all statistically different parameters remained significant. Complete remission rate, R1 resection rate, CRM positive or negative status, all in favor of chemoradiotherapy. Only the R0 resection rate was no more statistically different, but this did not translate into a better overall progression free survival or overall survival. But what is very important, is the effect of additional surgery. None of the patients without surgery survived five years, but 17.5% with additional surgery. Of course, these are no randomized data and are biased by patient selection, but it may show the important role of surgery of these patients.
Moreover, the best survival data we achieved for CRM or R0 resected patients was a five year survival rate of 35 to 27%. We found some hints that chemoradiotherapy improves this long term survival of surgically treated patients. Five year survival following chemoradiotherapy is 24% compared to 20% following chemotherapy alone. Of course, these results are not statistically different but may be a hint how the better R0 resection rate may potentially translate into a better survival.
In conclusion, we found that additional chemoradiotherapy to chemotherapy improves significantly the R0 resected rate, in surgically treated group but not in all randomized patients. Additional chemoradiotherapy improves the rate of R0 CRM negative resected significantly and very importantly, 36% of all randomized patients can be treated additionally with surgery, the five year survival of 17.5% compared to 0% without surgery. Overall this concept of induction chemotherapy, additional chemoradiotherapy and surgery, is visible, with a five year survival rate of 9.6% and selects a favorable subgroup of patients that has an impressive long term survival rate of up to 26%.
And the next steps in our analysis will be a further evaluation of prognostic parameters to select better patients who will benefit most from surgery and chemoradiotherapy.
Related Videos
The ASCO Post Staff
Richard Finn, MD, of the Geffen School of Medicine at UCLA and the Jonsson Comprehensive Cancer Center, discusses analyses from the PALOMA-2 trial on overall survival with first-line palbociclib plus letrozole vs placebo plus letrozole in women with ER-positive/HER2-negative advanced breast cancer. The study met its primary endpoint of improving progression-free survival but not the secondary endpoint of overall survival. Although patients receiving palbociclib plus letrozole had numerically longer overall survival than those receiving placebo plus letrozole, the results were not statistically significant (Abstract LBA1003).
The ASCO Post Staff
Pamela L. Kunz, MD, of the Yale University School of Medicine, discusses new findings from the ECOG-ACRIN E2211 trial, which showed the longest progression-free survival and highest response rates with temozolomide plus capecitabine reported to date for patients with pancreatic neuroendocrine tumors. The presence of a deficiency of MGMT, the drug-resistance gene, was associated with greater odds of an objective response (Abstract 4004).
The ASCO Post Staff
Erika Hamilton, MD, of Sarah Cannon Research Institute at Tennessee Oncology, discusses phase III data from the DESTINY-Breast03 study, which reinforced the consistent safety profile of fam-trastuzumab deruxtecan-nxki (T-DXd) vs ado-trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable and/or metastatic breast cancer. The findings also support T-DXd’s risk benefit over that of T-DM1 (Abstract 1000).
The ASCO Post Staff
Akihiro Ohba, MD, of Japan’s National Cancer Center Hospital, discusses phase II data from the HERB trial on fam-trastuzumab deruxtecan-nxki, which showed activity in patients with HER2-expressing unresectable or recurrent biliary tract cancer (Abstract 4006).
The ASCO Post Staff
Stephanie Walker, a former nurse and current activist with the Metastatic Breast Cancer Alliance, discusses findings from the BECOME project (Black Experience of Clinical Trials and Opportunities for Meaningful Engagement). They show that, even though Black patients comprise between 4% and 6% of all clinical trial participants, Black women with metastatic breast cancer are willing to consider taking part if steps were taken to increase their awareness, build trust through clear communication with health-care providers, involve people of shared racial/ethnic identity and health experience, and help patients find and access trials (Abstract 1014).
