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Read below for a recap of ASCO Day #1 highlights by Dr. Chandler Park, Doximity's Hematology/Oncology Ambassador.
ASCO Day #1 Recap:
Dr. Chandler Park [1:33 PM]
- Breast cancer will be one of the key early players at ASCO 2017
- Some of the key studies I noticed today include:
- Phase 3 APHINITY for HER2 breast cancer patients. Are we overtreating these patients for a small overall survival?
- OlympiAD study for PARP inhibitors for BRCA1 and BRCA2 mutated breast cancer patients Olaparib vs chemotherapy. This will be one of the major studies discussed at ASCO.
- The new CDK4/6 inhibitor studies. (Stay tuned for an interview with Dr. Jame Abraham (Director of Breast Medical Oncology at Cleveland Clinic) to help sort through the data)
Dr. Chandler Park [3:15 PM]
Just released, hot off the presses at ASCO, is the MONARCH-2 trial. This study will likely be in the next updated NCCN Breast guidelines for all cancer doctors.
Significance: Hormone receptor breast cancer patients who had progressed while receiving neoadjuvant or adjuvant endocrine therapy (ET), ≤ 12 months from the end of adjuvant ET, or while receiving first-line ET for metastatic disease. This study will make Abemaciclib and Fulvestrant a standard of care option. Abemaciclib plus fulvestrant increased PFS versus fulvestrant alone (median, 16.4 v9.3 months; hazard ratio, 0.553; 95% CI, 0.449 to 0.681; P < .001). Patients with measurable disease, abemaciclib plus fulvestrant achieved an ORR of 48.1% (95% CI, 42.6% to 53.6%) compared with 21.3% (95% CI, 15.1% to 27.6%) in the control arm. The most common adverse events in the abemaciclib versus placebo arms were diarrhea (86.4% v 24.7%), neutropenia (46.0% v 4.0%), nausea (45.1% v 22.9%), and fatigue (39.9% v 26.9%)
Current Standard: Breast oncologists currently use Pabociclib with Fulvestrant in this indication.
Practice changing: Perhaps. Abemaciclib and Palbociclib have different side effects. Abemaciclib appears to have more GI side effects especially diarrhea. Palbociclib appears to have more neutropenua.
Patient factors: Abemaciclib is a daily BID dosing. Palbociclib is once a day for 21 days on and 7 days off.
Last factor: Abemaciclib and Palbociclib are not identical drugs. Therefore more future clinical studies are needed to separate these drugs.
Dr. Chandler Park [EOD Check-in]
Two studies showed that we have a new 1st line treatment option for newly diagnosed high risk hormone sensitive metastatic prostate cancer. These studies are practice changing and will be updated in the next NCCN guidelines for Prostate Cancer.
Significance: New standard of care option for first line metastatic hormone sensitive prostate cancer with high risk features including Gleason scores greater than 7,, Visceral Metastases, or greater than 2 bone lesions. Minor concerns are increased cardiovascular risk due to hypertension and increased transaminitis.
Current Standard: Docetaxel with Androgen Deprivation Therapy for high risk metastatic prostate cancers. However Docetaxel increases treatment associated toxicities.
Practice Changing: Yes. Abiaterone moves up to first line for high risk metastatic hormone sensitive breast cancer. Select patients can still be considered for Docetaxel with Androgen Deprivation Therapy such as patients with strong cardiovascular comorbidities. Also patients with underlying liver disease since Abiaterone arm appears to worsen liver function. Will need more data for lower risk metastatic prostate cancer patients.
Two study recap below
- The LATITUDE trial Enrolled men who did not have previous Androgen Deprivation Therapy (ADT). These patients had at least 2 of 3 risk factors: Gleason score greater than or equal to 8, measurable visceral metastases, or greater than 2 bone lesions. The arm with Abiaterone, Prednisone, and Androgen Deprivation Therapy showed superior results compared to arm without Abiaterone.
At median follow up of 30.4 months, the median overall survival (OS) had not yet been reached (NR) in the abiraterone arm; the median OS in the control group was 34.7 months (HR, 0.62; 95% CI, 0.51-0.76; P<.0001). The OS rate at 3 years was 66% in the abiraterone group versus 49% with placebo.
PFS for Abiaterone, Prednisone, and Androgen Deprivation was 33 months compared to 14.8 months for Androgen Deprivation plus placebo in high risk metastatic prostate cancer (HR, 0.47; 95% CI, 0.39-0.55; P <.0001).
The abiraterone containing arm showed significantly improved secondary endpoints compared with the control group in the prostate specific antigen (PSA) progression (33.2 vs 7.4 months), chemotherapy (NR vs 38.9 months). Hazard ratio for endpoint is 0.30 for PSA.
Toxicities of the abiraterone arm resulted in higher rates of grade 3/4 adverse events compared with the control arm including hypertension (20.3% vs 10.0%); hypokalemia (10.4% vs 1.3%); abnormal liver functions tests including increased alanine aminotransferase (5.5% vs 1.3%), and increased aspartate aminotransferase (4.4% vs 1.5%).
- Stampede Trial of Abiraterone Patients in this first line study of locally advanced or metastatic prostate cancer was randomized to Abiraterone with Prednisone and Androgen Deprivation Treatment vs Androgen Deprivation Treatment alone. The arm that used Abiraterone, Prednisone, and ADT had a 71% relative improvement in the time to treatment failure which means a 37% difference in overall survival as compared to ADT alone arm.
At median follow up at 40 months, 184 deaths had occurred in the abiraterone group and 262 deaths in the standard therapy arm. The median adjusted HR for the median OS was 0.63 (95% CI, 0.52-0.76; P = .0000012). Abiraterone-containing therapy also demonstrated improved skeletal-related outcomes with a 55% reduction in the time for such problems to develop (HR, O.45; 95% CI, 0.36-0.38).
http://www.nejm.org/doi/pdf/10.1056/NEJMoa1702900
Editor's Note: Which studies did you find most interesting or impactful at ASCO Day #1? Share your opinions on and experiences at ASCO 2017 and your comments will be shared with all Hem/Onc physicians to discuss.