Ten Practice Changes I Will Make After Attending ASCO 2023
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I hopefully will have a treatment (vorasidenib) approved shortly to offer patients with resected IDH-mutated grade 2 oligodendroglioma or astrocytoma. Mellinghoff presented compelling data at the Plenary Session (LBA1). Patients randomized to the drug had a median PFS of 27.7 months as opposed to 11.1 months in placebo-treated patients. Questions obviously remain regarding the duration of response and effect on OS and how to use the drug in patients previously treated with chemotherapy and/or radiation therapy.
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I can now recommend eliminating the routine use of radiation in good- and intermediate-risk rectal cancer patients and reserve the treatment for those who fail to respond to upfront FOLFOX. Schrag presented the results from the large PROSPECT trial, which demonstrated noninferiority with the selective use of chemo-irradiation with the expected decrease in long-term toxicity (LBA2). The 5-year DFS was 80.8% in the 585 patients randomized to selective radiation and 78.6% in the 543 patients randomized to radiation as standard of care. OS and local RFS were similar in both groups as well.
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I can offer patients with stage III and IV Hodgkin’s lymphoma a regimen incorporating immunotherapy as first-line treatment. It appears to be more effective and less toxic than the BV-AVD regimen, which has become a standard of care. As reported by Herrera at the Plenary Session (LBA4), substituting nivolumab (N-AVD) for brentuximab vedotin in SWOG S1826 resulted in 1-year PFS improvement from 86% to 94%, with fewer deaths and fewer long-term toxicities such as neuropathy.
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I will offer selected patients with stage II and III NSCLC both preoperative and adjuvant immunotherapy in addition to neoadjuvant chemotherapy. Wakelee reported initial results from KEYNOTE-671 (LBA100) at a special session, which demonstrated improvement in DFS and trend in improvement in OS. The 397 patients who received pembrolizumab along with platinum-based treatment in the neoadjuvant setting followed by adjuvant pembrolizumab for up to 13 cycles had superior EFS compared with the 400 placebo patients (62.4% vs 40.6%) and superior OS (80.9% v 77.6%). The pathologic complete response rate was superior in the neoadjuvant pembrolizumab group (18.1% vs 4.0 %) as well.
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I now have an another option to add to adjuvant endocrine therapy in high-risk breast cancer patients. Slamon presented the first efficacy report from the NATALEE trial (LBA500). In total, 5101 patients were randomized to ribociclib or placebo for 3 years in addition to one of the nonsteroidal aromatase inhibitors. There was a significant improvement in 3-year iDFS in the ribociclib-treated patients as compared with those taking placebo, and the drug was quite tolerable. The 3-year iDFS improved from 87.1% to 90.4%, and there is a trend in improved OS as well. It should be noted that there was a broader eligibility requirement as compared with the PALLAS and monarchE trials and that the 400-mg dose of ribociclib was lower than that used to treat metastatic patients.
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I will not automatically add a CDK inhibitor to the therapy for all my patients with metastatic breast cancer receiving an aromatase inhibitor as first-line therapy. Sonke reported the results of the Dutch SONIA trial. PFS2 (the time from randomization to second objective disease progression or death) was equivalent if the CDK inhibitor was deferred and used with fulvestrant in those patients progressing on endocrine therapy alone. (LBA1000). Median PFS2 was 31.0 and 27.8 months, respectively, in the standard and delayed groups. Delaying CDK inhibition resulted in overall less toxicity and cost savings.
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When treating metastatic breast cancer patients with capecitabine, I will use the lower fixed-dose regimen of 1500 mg twice daily 7 days on/7 days off. As reported by Khan (ABS1007), this schedule was equally effective and less toxic than the higher dose schedule of 2 weeks on/1 week off. Median PFS was 13.9 months in the 7/7 group and 14.6 months in the control group. OS at 36 months was similar as well (21.2% vs 19.6 %). Grade 2–4 toxicity was reduced from 49% to 25% with the fixed lower dose. Only 7.5% of patients on the fixed-dose regimen discontinued treatment as opposed to 28.8% in those treated with the standard regimen.
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I will use the dose-dense MVAC regimen when treating muscle-invasive bladder cancer with neoadjuvant chemotherapy. Pfister presented the results of the French VESPER trial (LBA4507), which demonstrated that six cycles of ddMVAC resulted in an improvement in 5-year OS from 57% to 66% as opposed to four cycles of gemcitabine/cisplatin. It was important to maintain dose density to achieve these superior results.
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I will offer stage IIB and IIC melanoma patients adjuvant pembrolizumab. Luke presented 39-month follow-up of the KEYNOTE-716 study (LBA9505). The 487 patients randomized to 1 year of pembrolizumab had a 3-year distant metastasis–free survival of 84.4% compared with 74% in 489 placebo patients. Overall RFS was 76.2% versus 63.4 %. OS data are not mature yet; but, in prior adjuvant studies with biologics, there was a correlation between RFS and OS.
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I will now recommend to breast and GI cancer patients being treated with capecitabine to use over-the-counter 1% diclofenac gel (Voltaren) on their hands twice daily to decrease the incidence of hand–foot syndrome (HFS). The D-TORCH study reported by Batra (ABS12005) demonstrated a decrease in HFS grade 2 and higher and a decrease in capecitabine dose reduction, along with improved quality of life. Compared with a HFS rate of 18.1% in the 133 patients in the placebo group, the rate of HFS was 6.1% in the 130 patients treated with diclofenac gel. Only 3.8% of patients in the gel group required capecitabine dose reductions as opposed to 15% in the control group. All subgroups benefited, and the gel is nontoxic and relatively inexpensive.
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