The American Society of Clinical Oncology’s annual meeting is an excellent opportunity to learn about and assess new developments in cancer treatment. The solid tumor oncology staff of Cleveland Clinic Cancer Center’s Department of Hematology and Medical Oncology has compiled the following list of the top abstracts from ASCO 2018 that our physicians consider to be the most intriguing, the most clinically relevant or that have the greatest potential to change the practice of clinical oncology in the near future.
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TAILORx: Phase 3 trial of chemoendocrine therapy versus endocrine therapy alone in hormone receptor-positive, HER2-negative, node-negative breast cancer and an intermediate prognosis 21-gene recurrence score
Comment: This major, practice-changing trial helps us to tailor treatment based upon risk of recurrence and genomic information and suggests that we may be able to avoid chemotherapy for up to two-thirds of patients with breast cancer.
CARMENA: Cytoreductive nephrectomy followed by sunitinib versus sunitinib alone in metastatic renal cell carcinoma — results of a phase 3 noninferiority trial
Comment: This trial shows that some patients with metastatic renal cell carcinoma should not undergo cytoreductive nephrectomy, namely those with poor performance status and with a majority of tumor burden outside the kidney.
Unicancer GI PRODIGE 24/CCTG PA.6 trial: A multicenter international randomized phase 3 trial of adjuvant mFOLFIRINOX versus gemcitabine (gem) in patients with resected pancreatic ductal adenocarcinomas
Comment: This pancreatic cancer abstract has the best outcomes ever reported for resected pancreatic cancer and creates a new standard of care for adjuvant therapy.
A phase 1 study of LOXO-292, a potent and highly selective RET inhibitor, in patients with RET-altered cancers.
Comment: RET fusion-positive lung adenocarcinoma represents about 2 percent of all patients with non-small cell lung cancer, but to date RET-targeted therapies have had little impact on this unique subgroup of patients. This phase 1 trial using a highly specific RET inhibitor (LOXO-292) demonstrated a 69 percent response rate in patients with RET-fusion+ cancers including lung cancer, with minimal side effects. This represents an exciting new treatment option for these patients.
Phase 3 study of carboplatin-paclitaxel/nab-paclitaxel (chemo) with or without pembrolizumab (pembro) for patients (pts) with metastatic squamous (sq) non-small cell lung cancer (NSCLC)
Comment: This study showed a significant and clinically meaningful improvement in overall survival in the pembro arm, and importantly the survival benefit was seen in all levels of PDL1 expression including < 1 percent. This trial immediately change standard practice for patients with advanced squamous NSCLC.
PERSEPHONE: 6 versus 12 months (m) of adjuvant trastuzumab in patients (pts) with HER2 positive (+) early breast cancer (EBC): Randomised phase 3 non-inferiority trial with definitive 4-year (yr) disease-free survival (DFS) results
Comment: This trial is an excellent example of optimizing treatment based upon risk. In some HER2-positive patients, we reduce trastuzumab treatment from one year to six months to achieve the same benefit.
Pembrolizumab monotherapy as first-line therapy in advanced clear cell renal cell carcinoma (accRCC): Results from cohort A of KEYNOTE-427
Comment: This study shows that pembrolizumab monotherapy has substantial activity in accRCC and could have a therapeutic role alongside emerging combination regimens.
Definitive cetuximab-based (CRT-CX) vs. non-cetuximab based chemoradiation (CRT) in older patients with squamous cell carcinoma of the head and neck (HNSCC): analysis of the SEER-Medicare linked database
Comment: The optimal nonoperative approach for elderly patients with locally advanced head and neck squamous cell cancer has not been defined. Clinical trials and meta-analyses have suggested that neither radiation with concurrent chemotherapy, nor radiation with concurrent cetuximab are any more effective than radiation therapy alone. This retrospective, large data set analysis compared the results of using these three approaches in an older population, and found that radiation and concurrent chemotherapy was clearly better. Radiation alone and radiation with cetuximab were equivalent and distinctly inferior. While these results to a large extent reflect physician selection bias, the outcomes were confirmed in a multivariable analysis which considered comorbidity, site, stage, gender, race and income. Although this report is not practice-changing, it is practice affirming. The use of concurrent chemoradiotherapy can be considered appropriate in carefully selected elderly patients with this disease.
Final analysis of DeCOG-SLT trial: survival outcomes of complete lymph node dissection in melanoma patients with positive sentinel node
Comment: The multicenter, randomized, phase 3 DeCOG-SLT trial assessed whether complete lymph node dissection (CLND) resulted in increased survival compared with observation in patients with positive sentinel node biopsy (SLNB). This study gave an update three years after inclusion of the last patient. After a median follow-up time of 72 months, there was no survival benefit in melanoma patients with positive SLNB undergoing CLND compared to observation only. These data are consistent with the prior multinational study MSLT-II and further support minimizing the use of CLND after a positive SLNB.
Primary analysis of phase 2 results for cemiplimab, a human monoclonal anti-PD-1, in patients with metastatic cutaneous squamous cell carcinoma (mCSCC)
Comment: Based on the phase 1 and 2 data, the FDA granted a priority review in April 2018 and is scheduled to make its decision on the Biologics License Application by October 2018. mCSCC is relatively rare, so larger studies are not expected, but the data here is convincing and likely to bring FDA approval.
First-of-its-kind research investigates the viability of standard screening to reduce the burden of late-stage cancer diagnoses
Study demonstrates ability to reduce patients’ reliance on phlebotomies to stabilize hematocrit levels
Findings highlight an association between obesity and an increased incidence of moderate-severe disease
Cleveland Clinic Cancer Institute takes multi-faceted approach to increasing clinical trial access
Gene editing technology offers promise for treating multiple myeloma and other hematologic malignancies, as well as solid tumors
Study of 401,576 patients reveals differences in cancer burdens as well as overall survival
Enfortumab plus pembrolizumab reduced risk of death by 53% compared with platinum-based chemotherapy