Each month, Oncology Nursing News® takes a look back at our most popular stories.
In July 2023, it was announced that the manufacturers of pralsetinib (Gavreto) would be voluntarily withdrawing the agent’s indication for advanced or metastatic RET-positive medullary thyroid cancer. The FDA announced that capivasertib plus fulvestrant (Faslodex) has received priority review and is being considered as a treatment option for patients with hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer.
Data was published demonstrating that intra-arterial gemcitabine plus nab-paclitaxel outperformed intravenous gemcitabine plus nab-paclitaxel (Abraxane) in improving overall survival in locally advanced pancreatic cancer. In addition, findings from a cross-institutional study suggest that on-pathway regimens were associated with lower overall costs for patients with cancer, although hospitalization and toxicity rates remain the same.
Finally, Kristin Barber, APRN, AOCNP, FNP-BC, provided an in-depth look at tucatinib (Tukysa) and trastuzumab (Herceptin) in a downloadable fact sheet.
Below are the top 5 articles from July 2023. For more, please sign-up for our newsletter.
Tucatinib was first approved by the FDA for the treatment of patients with HER2-positive advanced unresectable or metastatic breast cancer in combination with trastuzumab and capecitabine (Xeloda) on April 17, 2020. This drug combination was approved for patients who had received 1 or more anti–HER2-based regimens for metastatic breast cancer, including those with brain metastases.
More recently, tucatinib, in combination with trastuzumab, was granted accelerated approval by the FDA on January 19, 2023, for the treatment of patients with unresectable or metastatic colorectal cancer (mCRC) whose disease is RAS wild-type and HER2-positive, following progression after fluoropyrimidine, oxaliplatin, and irinotecan–based chemotherapy.
Pralsetinib will no longer be available as a treatment option for patients with advanced or metastatic RET-positive medullary thyroid cancer, as the manufacturers involved in its development have chosen to withdraw the indication in the United States.
According to a news release, the decision was made in collaboration with the FDA, because the phase 3 AcceleRET-MTC trial (NCT04760288) needed to convert the agent’s accelerated approval into a full approval is no longer feasible, they said. They also stated that the decision to withdraw the indication was not because of any new safety or efficacy data.
Capivasertib plus fulvestrant has been granted priority review by the FDA. The regimen is being considered as a treatment for patients with hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer following recurrence or progression on or after endocrine-based therapy.
The designation is based on data from the phase 3 CAPItello-291 trial (NCT04305496), which demonstrated a 40% reduction in the risk of disease progression or death with the addition of the AKT inhibitor to endocrine therapy with fulvestrant (n = 355) vs fulvestrant plus placebo (n = 353) in this population. Median progression-free survival was 7.2 months (95% CI, 5.5-7.4) and 3.6 months (95% CI, 2.8-3.7) with the combination and fulvestrant alone, respectively (HR, 0.60; 95% CI, 0.51-0.71. P < .001)
Compared with intravenous (IV) gemcitabine plus nab-paclitaxel (Abraxane), intra-arterial (IA) gemcitabine was associated with improved overall survival (OS) among patients with locally advanced pancreatic cancer who had already undergone treatment with IV gemcitabine, nab-paclitaxel, and radiotherapy, according to data from the first interim analysis of phase 3 TIGeR-PaC trial (NCT03257033).
Data presented at the 2023 ESMO World Congress on Gastrointestinal Cancer showed that patients treated with IA gemcitabine (n = 23) experienced a median OS of 15.7 months compared with 10.1 months for those who continue with IV gemcitabine and nab-paclitaxel (n = 22; HR, 0.48; 95% CI, 0.20-1.12; P < .08).
Findings from a cross-institutional study suggest that, for patients with cancer, on-pathway regimens led to significant cost savings, although the rate of hospitalizations and immune-related adverse events were similar between on-pathway and off-pathway regimens. The results were published in the Journal of Clinical Oncology.
On average, prescribing on-pathway regimens led to a $17,589 reduction in total health care cost per patient (95% CI, –$23,790 to –$11,388; P < .001) and a $22,543 reduction in chemotherapy cost per patient (95% CI, –$27,666 to –$17,420; P < .001).
“Among patients who received first-line cancer treatment for metastatic solid tumors, use of [Cancer Care Quality Program]-endorsed on-pathway treatment regimens was associated with significant cost savings,” Ying Liu, PhD, of Elevance Health, and co-investigators wrote in the study. “Overall, there was a significant reduction in total health care cost for patients prescribed with on-pathway regimens, driven mainly by the lower cancer drug costs for this group.”