November 2022 Archives - FCS Hematology Oncology Review

Phase II Randomized Study of Salvage Radiation Therapy Plus Enzalutamide or Placebo for High-Risk Prostate-Specific Antigen Recurrent Prostate Cancer After Radical Prostatectomy: The SALV-ENZA Trial

November 11, 2022

Although not a practice changing study, this study makes a few points that may be seen in future studies. In the setting of biochem-recurrent prostate cancer after RP, novel anti-androgen agents may replace ADT in combination with salvage XRT as they appear to be active and less toxic than traditional ADT. Low/Intermediate risk patients are likely of benefit with median PSA at accrual of 0.3 in this study, not unlike other similar studies. The role of combination anti-hormone therapy + salvage radiation seems to be solidifying.

Trastuzumab Deruxtecan in Anti–Human Epidermal Growth Factor Receptor 2 Treatment–Naive Patients With Human Epidermal Growth Factor Receptor 2–Low Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Cohort Results in a Phase II Trial

November 1, 2022

Her2-low is here to stay. Expect further studies on Enhertu and Trodelvy on gastroesophageal Her-2 low patients. Response rates were modest however, so temper expectations as single agent therapy. I look forward to trials on future combination therapy.

Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non–Small-Cell Lung Cancer: The Phase III POSEIDON Study

November 1, 2022

Suddenly met-NSCLC is a crowded space. This study did not conclude that T+D+CT was better than D+CT, the findings showed that D+CT was better than CT alone. The addition of T to D+CT improved the PFS and OS trend but I don’t think this was a homerun result. There was not a significant OS benefit and further follow-up will declare these results. Also an improved outcomes were not seen in the non-squamous population. The pembrolizumab studies have 5+ years of follow-up and an improvement in PFS and OS across NSCLC subtypes.

Phase II Study of Venetoclax Added to Cladribine Plus Low-Dose Cytarabine Alternating With 5-Azacitidine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

November 1, 2022

The combination of venetoclax and 5-azacitidine (5-AZA) for older or unfit patients with acute myeloid leukemia (AML) improves remission rates and survival compared with 5-AZA alone.

Primary Retroperitoneal Lymph Node Dissection for Patients With Pathologic Stage II Nonseminomatous Germ Cell Tumor—N1, N2, and N3 Disease: Is Adjuvant Chemotherapy Necessary?

November 1, 2022

Thought provoking retrospective study regarding primary RPLND for stage II NSGCT. Study found that after RPLND N1-3 disease had a recurrence rate of about 20%, which flattens at years 2 to 5, and in patients who recurred all were treated successfully with chemotherapy. Adjuvant chemotherapy is preferred on the NCCN for post-RPLND patients who are pN2-N3, however this suggests close surveillance may be an option in centers with high surgical expertise.

Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: a multicentre, single-arm, phase 2 trial

November 1, 2022

Interesting non-operative approach for T1-2, N0-1, M0 TNBC or HER2+ breast cancer, 58 patients enrolled in this single center phase II out of MDA. 62% of patients had CR on biopsy after systemic therapy, if results hold true over a longer follow-up period this may be of significant impact.

Efficacy and Safety of Intravenous Efgartigimod in Adults with Primary Immune Thrombocytopenia: Results of a Phase 3, Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial (ADVANCE IV)

November 1, 2022

Another new (potential) option for refractory ITP patients, efgartigimod is an IgG1-Fc-fragment engineered to reduce IgG autoantibody levels. 131 patients enrolled and 67% had >=3 prior lines of therapy, placebo controlled study. The study group had a 90% sustained platelet response, with >50% having plt counts of >30k >= 7 days apart.

Low-Intensity Adjuvant Chemotherapy for Breast Cancer in Older Women: Results From the Prospective Multicenter HOPE Trial

November 1, 2022

Older women with high-risk early breast cancer (EBC) benefit from adjuvant chemotherapy, but their treatment is frequently complicated by toxic side effects, resulting in dose reductions and delays.

Efficacy and Safety of Ibrutinib Combined with Standard First-Line Treatment or As Substitute for Autologous Stem Cell Transplantation in Younger Patients with Mantle Cell Lymphoma: Results from the Randomized Triangle Trial By the European MCL Network

November 1, 2022

Potentially practice changing trial from the EU on young, transplant eligible patients with MCL were all treated with first line chemo then randomized to Auto-HSCT +/- Ibrutinib. The addition of Ibrutinib to Auto-HSCT improved DFS compared to Auto-HSCT alone, and more interestingly patients treated Ibrutinib was better than those who had transplant but the data on the Ibrutinib vs traplant + Ibrutinib arms are premature. The addition of maintenance Rituximab did not seem to change any outcomes.

Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer

November 1, 2022

Long term results on adjuvant FOLFIRINOX vs Gem in adjuvant pancreatic cancer. Although the survival benefit is quite significant (OS 53.5 vs 35.5 months respectively), I think the tell-tale numbers are the 5 year DFS being 26.1 vs 19%. The modest 7% curative benefit of triplet vs single agent chemotherapy highlights the difficulty in managing this disease and the continued need for investment in GI clinical trials.

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Phase II Randomized Study of Salvage Radiation Therapy Plus Enzalutamide or Placebo for High-Risk Prostate-Specific Antigen Recurrent Prostate Cancer After Radical Prostatectomy: The SALV-ENZA Trial

Trastuzumab Deruxtecan in Anti–Human Epidermal Growth Factor Receptor 2 Treatment–Naive Patients With Human Epidermal Growth Factor Receptor 2–Low Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Cohort Results in a Phase II Trial

Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non–Small-Cell Lung Cancer: The Phase III POSEIDON Study

Phase II Study of Venetoclax Added to Cladribine Plus Low-Dose Cytarabine Alternating With 5-Azacitidine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Primary Retroperitoneal Lymph Node Dissection for Patients With Pathologic Stage II Nonseminomatous Germ Cell Tumor—N1, N2, and N3 Disease: Is Adjuvant Chemotherapy Necessary?

Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: a multicentre, single-arm, phase 2 trial

Efficacy and Safety of Intravenous Efgartigimod in Adults with Primary Immune Thrombocytopenia: Results of a Phase 3, Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial (ADVANCE IV)

Low-Intensity Adjuvant Chemotherapy for Breast Cancer in Older Women: Results From the Prospective Multicenter HOPE Trial

Efficacy and Safety of Ibrutinib Combined with Standard First-Line Treatment or As Substitute for Autologous Stem Cell Transplantation in Younger Patients with Mantle Cell Lymphoma: Results from the Randomized Triangle Trial By the European MCL Network

Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer

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