Prospective pooled analysis of six phase III trials investigating duration of adjuvant oxaliplatin-based therapy (3 vs 6 months) for patients with stage III colon cancer: The IDEA (International Duration Evaluation of Adjuvant chemotherapy) collaboration
“The question of 3 months or 6 months of adjuvant chemotherapy for stage III colon cancer will be an evolving story,” Prunella Blinman
This plenary presentation was a pooled analysis of >12,800 patients from 6 trials that aimed to determine whether 3 months of adjuvant chemotherapy (FOLFOX or CAPOX) for stage III colon cancer was non-inferior to 6 months of the same treatment. The non-inferiority design (with an upper 95% CI limit of 1.13) was driven by the goal of giving less chemotherapy to reduce the neurotoxicity of 6 months of oxaliplatin, as long as less chemotherapy is no worse. Non-inferiority of 3 months versus 6 months of chemotherapy was not shown in the whole study population (3y DFS 74.6% v 75.5%, HR 1.07 95% CI 1.00-1.15). There was, however, a regimen and substage effect: non-inferiority was shown in patients who had CAPOX or who had T1-3/N1 cancers, but was not shown in patients who had FOLFOX or who had T4/ N2 cancers. These results were mirrored in subsequent presentations of the results of 3 of the trials in the IDEA collaboration.
The question of 3 months or 6 months of adjuvant chemotherapy for stage III colon cancer will be an evolving story. One view is that the overall results of the pooled analysis do not change the current standard of care, that is, 6 months of adjuvant chemotherapy for all patients. An alternate view is to use the results to tailor treatment such as considering 3 months of CAPOX for patients with T1-3/N1 cancers.
Overall survival results of a randomized trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment
“The main limitation to implement a similar intervention in Australia is resources and funding and the often low priority given to supportive care,” Prunella Blinman
This plenary presentation was the overall survival (OS) results of a simple, well-designed, randomised trial of a ‘PRO intervention’ consisting of the self-report of 12 common symptoms by tablet computer versus usual care in 766 patients having chemotherapy for an advanced cancer. Already reported benefits of the PRO intervention were improved quality of life and patient satisfaction and reduced presentations to emergency. The absolute median OS benefit was 5 months in favour of the PRO intervention arm compared with usual care (31.2m v 26.0m, p=0.03).
It was great to see a trial of a patient-centred intervention as a plenary presentation. For perspective, the OS benefit of this trial is much greater than the OS benefit of many palliative systemic therapies used in advanced cancer. Whilst the PRO intervention seemed feasible and acceptable, the main limitation to implement a similar intervention in Australia is resources and funding and the often low priority given to supportive care.
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Alectinib versus crizotinib in treatment-naive advanced ALK-positive non-small cell lung cancer (NSCLC): Primary results of the global phase III ALEX study
“I chose this abstract not only because it sets a new standard for care for patients with ALK + advanced NSCLC, but also as an example of the exciting pace of lung cancer research,” Prunella Blinman
This abstract reported a randomised phase III trial of first-line alectinib versus crizotinib in a global population of patients with ALK + advanced NSCLC. Of note, patients with asymptomatic brain metastases were included. Alectinib had clearly superior PFS (HR 0.47, p<0.0001, mPFS NR for alectinib v 11.1m for crizotinib), CNS response (17/21, 80% for alectinib v 11/22, 51% for crizotinib) and more favourable toxicity profile.
I chose this abstract not only because it sets a new standard for care for patients with ALK + advanced NSCLC, but also as an example of the exciting pace of lung cancer research which has been part of my story as a clinician. I was present at ASCO 2010 when the data of the Phase 1/2 trial of crizotinib in ALK + advanced NSCLC was presented in the plenary session, and remember the buzz then generated by the new targeted therapy agent on the block. Seven years later, there is a new standard of care for first-line treatment of ALK + NSCLC with more trials of other second-generation ALK inhibitors underway.
Image Credit: Photo by © ASCO/Scott Morgan 2017