At least one of the abstracts highlighted at the press briefing of the American Society of Clinical Oncology (ASCO) on Wednesday threw an involuntary highlight on the problems that can beset cancer treatment even in successful trials.
The press briefing accompanied the release of abstracts and provided a preview on six of the studies that will be presented at the meeting in Chicago in June.
The work highlighted by ASCO in its briefing included a study reporting that using Iressa (gefitinib) reduced the risk of lung cancer recurrence relative to chemotherapy.
The CTONG 1104 randomized phase III trial treated 222 patients who were diagnosed with stage II-IIIA non-small-cell lung cancer (NSCLC) and had activating EGFR mutations in the tumor. Patients received either two years of treatment with Iressa, or four cycles of chemotherapy, which took 12 weeks to complete, with vinorelbine and cisplatin.
Treatment with Iressa delayed recurrence "by about 10 months," said presenter Yi-Long Wu, director of the Guangdong Lung Cancer Institute in Guangzhou, China.
Iressa-treated patients also experienced serious side effects at one quarter the rate of those treated with chemotherapy, and the side effect profile differed between the two groups. In the Iressa-treated group, the most common serious adverse event was high levels of the liver enzyme ALT and AST, while frequent chemotherapy side effects included neutropenia, nausea and vomiting.
But if those results sound good, they come at a price. At several prices, actually.
The obvious price is the financial one.
"It cannot be lost on all of us that the cost of gefitinib treatment is far, far greater than the cost of 12 weeks of chemotherapy," ASCO chief medical officer Richard Schilsky told reporters while discussing the results. In a medical system already straining under the cost of care, adding a treatment whose list price adds up to more than $150,000 over the course of two years is likely to result in payer pushback.
Opting for two years of Iressa over 12 weeks of chemotherapy is also "a big commitment on the part of patients," he added.
Finally, the trial shows that recurrence, progression and overall survival do not proceed in lockstep.
So far, gefitinib has not led to an overall survival benefit in the study. To date, in fact, more patients have died in the gefitinib group than in the group receiving chemotherapy, at 41 vs. 35.
Whether the study leads to changes in the way EGFR-mutated lung cancer is treated, ASCO's president-elect Bruce Johnson said, will depend heavily on whether treatment actually prolongs survival in longer follow-up study.
Schilsky said that in the short term, the biggest changes may come in diagnosis rather than treatment. "With this information now available I suspect what will happen is that many doctors will begin testing these tumors right after surgery," he said. Right now, testing for EGFR mutations is usually done only when tumors recur.
In terms of whether the results should change the way lung tumors are treated, though, "there is lots yet to be considered here."
Johnson agreed, adding that "this data is only a few weeks old. I haven't changed my approach yet, but I will be following this very closely to see what happens to the survival."
The better news at the press conference came from abstracts that were not looking at drugs. In fact, perhaps the easiest-to-follow implication of the highlighted abstracts was that if you do it right, happy hour cuts the risk of colon cancer recurrence.
In separate abstracts describing findings of the CALGB 89803 (Alliance) study, researchers reported that both light to moderate alcohol intake and the consumption of tree nuts (but not peanuts, which are technically legumes from a nutritional standpoint) protected against recurrence in the trial, which followed roughly 1,000 patients with stage III colon cancer for eight to 10 years after surgery.
Participants were not randomized to dietary groups, which leaves open the possibility of confounding factors. But the trial was prospective, so that at least the data on nut consumption are likely to be more accurate than retrospective studies that rely on patients' memories of their dietary patterns months or even years after the fact.
And following reports last year that CALGB 89803 participants also did better if they drank coffee, the studies that will be presented at ASCO add to the evidence that lifestyle is not just important for cancer prevention, but also in already diagnosed patients and that "lifestyle" is not necessarily a euphemism for "deprivation."