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Top 8 lessons learned at ASCO 2014
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The theme of this year’s ASCO Annual Meeting, “Science and Society,” emphasized patient-centered focus — looking at the full implications of a study result for patient quality of life — and the overall societal value, or significance, of a finding or treatment.
“In the past, it’s been sufficient to say, ‘This is a statistically significant result, end of discussion,’” Peter P. Yu, MD, incoming president of ASCO, told HemOnc Today. “This year, we tried to push the presenters and discussants to address the question of how their findings fit into the context of alternate treatments that are already available. We encouraged them to ask themselves, ‘Is this a significant advance? Is this a new standard of care?’”
Besides considering the potential toxicities or adverse effects of a treatment, Yu said any meaningful discussion of value, like it or not, must also address the issue of cost.
“Society has to deal with this question — can we afford every single new finding that comes along?” he said.
Clifford A. Hudis
According to 2013-2014 ASCO President Clifford A. Hudis, MD, it is possible for clinicians to consider the financial aspects of cancer treatment without compromising patient outcomes and quality of life.
“We think it’s entirely possible to improve the quality of care that patients get and improve their outcomes while, in fact, still making sure that we’re responsible in our use of resources.”
It was with this theme in mind that oncologists told HemOnc Today their selections for the top lessons learned at ASCO 2014.
1. In patients with premenopausal breast cancer, hormone suppression plus an aromatase inhibitor may increase survival, but also may affect quality of life.
In a joint analysis of the International Breast Cancer Study Group’s TEXT and SOFT trials, researchers found that in premenopausal women with hormone receptor-positive early breast cancer, a regimen of adjuvant exemestane, an aromatase inhibitor, plus ovarian function suppression, resulted in improved 5-year survival vs. tamoxifen plus ovarian function suppression.
Yu said this finding was positive, but the 3.8% improvement was modest, and the potential adverse effects should be considered.
“There is a new standard here; aromatase inhibitors can be used in this manner, and there’s a statistically significant benefit, although it’s not huge,” Yu said. “And these women are being put into early menopause, so there will be side effects in terms of bone health, libido and hot flashes. So, the physician needs to present this completely to the patient so they can make an informed decision.”
2. In women with hormone receptor-negative premenopausal breast cancer, chemotherapy plus ovarian suppression appears to score a “win-win.”
In a phase 3 study of premenopausal women with hormone receptor-negative breast cancer, the addition of the hormone suppressing drug goserelin (Zoladex, AstraZeneca) to a chemotherapy regimen decreased the risk for chemotherapy-related premature ovarian failure by 64%. Additionally, this combination was found to increase survival, and in an unexpected finding, it increased the likelihood of becoming pregnant and delivering a child.
“Now, this is what we call a patient-centric finding,” Yu said. “There was a statistically significant improvement in survival, and the women not only retained ovarian function, but also were able to become pregnant.”
3. Among men with metastatic, hormone-sensitive prostate cancer, the early addition of docetaxel chemotherapy to androgen deprivation therapy improves survival compared with ADT.
In a study of 790 men with metastatic, castration-resistant prostate cancer, adding chemotherapy treatment with docetaxel to a regimen of ADT conferred an impressive result of a 13.6-month increase in median survival.
Maha H. Hussain
“This is really an exciting development in the treatment of patients with this disease,” said Maha H. Hussain, MD, FACP, FASCO, professor of medicine and urology at the University of Michigan. “Docetaxel improved survival by more than 13 months in the group as a whole and 17 months in the subgroup of patients with high-volume cancer. The findings were unprecedented.”
Hudis agreed that the results were impressive, particularly in the high-volume subgroup.
“It’s remarkable that in this subgroup of men with advanced disease, they had about a year and a half extension of their lives, just by getting chemotherapy earlier,” he said.
4. Sometimes, a “negative” finding reveals something positive.
A study comparing first-line bevacizumab- (Avastin, Genentech) or cetuximab (Erbitux, ImClone)-based chemotherapy in patients with KRAS wild-type, metastatic colorectal cancer found no difference between the two. However, Hudis said there was a great deal of positive news beneath the surface of this negative finding.
“The median OS for these patients was about 29 months,” he said. “That’s remarkably better than it was just 10 years ago, when it measured in the low teens. What this study demonstrates is that metastatic colon cancer is an increasingly controllable disease, with outcomes getting better and better over the years.”
5. Identifying important biomarkers may spare patients unnecessary treatments.
Hussain said she was impressed with a study about the value of androgen receptor splice variant 7 in predicting outcomes of treatment with enzalutamide (Xtandi, Astellas Pharma) and abiraterone (Zytiga, Janssen Biotech) for metastatic castration-resistant prostate cancer. The study results found that detection of androgen receptor slice variant 7 in the circulating tumor cells of men with this disease is predictive of resistance to enzalutamide and abiraterone.
“The data suggest that, in the presence of this splice variant, the odds of responding to treatment are lower,” Hussain said. “That’s why this is important; it can allow us to pre-select for treatment those who are likely to respond, and spare those who are not likely to respond, the risk and cost of this treatment. These data, however, need to be validated.”
6. Sometimes, effective treatments have side effects, but sometimes the side effects are tolerable.
Yu cited a study in which a combination of the anti-angiogenesis drug cediranib (AstraZeneca), combined with the PARP inhibitor olaparib (AstraZeneca), significantly increased PFS in patients with recurrent ovarian cancer vs. olaparib alone.
Although the survival data were impressive, Yu said there was a downside to these findings. “The toxicities were much higher in the combination group; 70% of the combination patients had grade 3 or worse toxicities, while 7% of those on olaparib alone had these toxicities,” he said. “These side effects were mainly diarrhea, fatigue and hypertension, but still — a 10-fold increase. That just highlights that even when you have a dramatic improvement in a traditional measure of outcome, it might present quality-of-life issues to the patient.”
7. Treatments are evolving, even if they are evolving slowly.
Hussain cited a study of MPDL3280A, a PD-L1 inhibitor, which demonstrated a 50% response rate in patients with metastatic urothelial bladder cancer.
“In bladder cancer, there have been zero FDA-approved agents in over 20 years,” she said. “But the preliminary data for this immune drug are exciting, and it opens up the door to further investigations in different disease settings.”
8. Sometimes, disappointing findings can delay drug development.
Hudis said findings with lapatinib (Tykerb, SmithKline Beecham), which had previously shown promise in preoperatively targeting the HER receptor in breast cancer, did not improve outcomes for early-stage, HER-positive breast cancer in a study presented at this year’s meeting.
“Unfortunately, the study disappointed in that regard,” Hudis said. “There may be some reasons why the drug wasn’t so well tolerated, or why it wasn’t as effective as some others in advanced disease, but what this does say is that right now, we don’t yet know fully how to use the improved activity of some drugs preoperatively to completely predict what they will give the population in terms of OS.” – by Jen Byrne
Disclosure: Hudis and Yu report no relevant financial disclosures. Hussain reports receiving research support through University of Michigan contracts with Abbott, Astellas/Medivation, Genentech, Lilly/ImClone, Merck Serono, Millennium and Pfizer. She also reports consulting for Johnson & Johnson and Paradigm.