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ASCO DAILY NEWS
ASCO Daily News is the official conference reporter of the American Society of Clinical Oncology (ASCO), providing high-quality, unbiased research summaries and oncology news to ASCO members and oncology health care providers. JOURNAL OF CLINICAL ONCOLOGY Journal of Clinical Oncology (JCO) is a high-impact, peer-reviewed medical journal that publishes significant clinical oncology research along with editorials, reviews, and other works that relate to the care of patients with cancer. KEYNOTE-177: PHASE III RANDOMIZED STUDY OF PEMBROLIZUMAB 6 Background: KEYNOTE-177 (NCT02563002) evaluated the antitumor activity of pembrolizumab (pembro) vs chemotherapy ± bevacizumab or cetuximab (chemo) as first-line therapy for patients with microsatellite-instability high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC). We present results of the final PFS analysis and analysis of PFS2. Methods: Patients with PHASE II STUDY OF MAINTENANCE RUCAPARIB IN PATIENTS WITH PURPOSE Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi), is approved as maintenance therapy for patients with advanced pancreatic cancer (PC) and a germline BRCA1 or BRCA2 pathogenic variant (PV). This investigator-initiated, single-arm phase II study assessed the role of the PARPi rucaparib as maintenance therapy in advanced PC with germline or somatic PV in BRCA1, FIRST RESULTS FROM THE PHASE 3 CHECKMATE 274 TRIAL OF 391 Background: The standard of care (SOC) for patients (pts) with MIUC is radical surgery ± cisplatin-based neoadjuvant chemotherapy (chemo), but many pts are cisplatin-ineligible. There is no conclusive evidence supporting adjuvant chemo in pts who did not receive neoadjuvant chemo and in those with residual disease after neoadjuvant cisplatin. This phase 3 trial of adjuvant nivolumab (NIVO NAXITAMAB-BASED CHEMOIMMUNOTHERAPY FOR RESISTANT HIGH-RISK 10025 Background: Chemoresistant and relapsed disease are major obstacles to curing high-risk neuroblastoma (HR-NB). Anti-GD2 monoclonal antibody (MoAb) is effective in preventing relapse after remission but responses in relapsed or progressive disease (PD) are rare. We investigated the combination of humanized anti-GD2 MoAb naxitamab, (previously termed Hu3F8), irinotecan, TALAZOPARIB BEYOND BRCA: A PHASE II TRIAL OF TALAZOPARIB 3006 Background: Talazoparib, a PARP inhibitor, is active in germline BRCA1/2 mutant advanced HER2-negative breast cancer, but its activity beyond BRCA1/2 is unknown. We conducted a single institution phase II trial to evaluate talazoparib in patients (pts) with advanced HER2-negative breast cancer or other solid tumors with a germline (g) or somatic (s) alteration in HR pathway genes not SAFETY AND CLINICAL ACTIVITY OF DURVALUMAB MONOTHERAPY IN 4071 Background: Durvalumab, an anti-PD-L1 mAb, has shown early and durable clinical activity with manageable safety in an ongoing Phase 1/2, multicenter, open-label study in pts with advanced solid tumors. Interim analyses from the HCC cohort in the dose-expansion part of this study are reported here. Methods: Patients with HCC (Child-Pugh class A) received durvalumab 10 mg/kg i.v. q2w for 12 MANAGEMENT OF IMMUNE-RELATED ADVERSE EVENTS IN PATIENTS Purpose To increase awareness, outline strategies, and offer guidance on the recommended management of immune-related adverse events in patients treated with immune checkpoint inhibitor (ICPi) therapy. Methods A multidisciplinary, multi-organizational panel of experts in medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, CURRENT ISSUE TABLE OF CONTENTS American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options. Schnipper et al. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. Basch et al.ASCO DAILY NEWS
ASCO Daily News is the official conference reporter of the American Society of Clinical Oncology (ASCO), providing high-quality, unbiased research summaries and oncology news to ASCO members and oncology health care providers. JOURNAL OF CLINICAL ONCOLOGY Journal of Clinical Oncology (JCO) is a high-impact, peer-reviewed medical journal that publishes significant clinical oncology research along with editorials, reviews, and other works that relate to the care of patients with cancer. KEYNOTE-177: PHASE III RANDOMIZED STUDY OF PEMBROLIZUMAB 6 Background: KEYNOTE-177 (NCT02563002) evaluated the antitumor activity of pembrolizumab (pembro) vs chemotherapy ± bevacizumab or cetuximab (chemo) as first-line therapy for patients with microsatellite-instability high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC). We present results of the final PFS analysis and analysis of PFS2. Methods: Patients with PHASE II STUDY OF MAINTENANCE RUCAPARIB IN PATIENTS WITH PURPOSE Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi), is approved as maintenance therapy for patients with advanced pancreatic cancer (PC) and a germline BRCA1 or BRCA2 pathogenic variant (PV). This investigator-initiated, single-arm phase II study assessed the role of the PARPi rucaparib as maintenance therapy in advanced PC with germline or somatic PV in BRCA1, FIRST RESULTS FROM THE PHASE 3 CHECKMATE 274 TRIAL OF 391 Background: The standard of care (SOC) for patients (pts) with MIUC is radical surgery ± cisplatin-based neoadjuvant chemotherapy (chemo), but many pts are cisplatin-ineligible. There is no conclusive evidence supporting adjuvant chemo in pts who did not receive neoadjuvant chemo and in those with residual disease after neoadjuvant cisplatin. This phase 3 trial of adjuvant nivolumab (NIVO NAXITAMAB-BASED CHEMOIMMUNOTHERAPY FOR RESISTANT HIGH-RISK 10025 Background: Chemoresistant and relapsed disease are major obstacles to curing high-risk neuroblastoma (HR-NB). Anti-GD2 monoclonal antibody (MoAb) is effective in preventing relapse after remission but responses in relapsed or progressive disease (PD) are rare. We investigated the combination of humanized anti-GD2 MoAb naxitamab, (previously termed Hu3F8), irinotecan, TALAZOPARIB BEYOND BRCA: A PHASE II TRIAL OF TALAZOPARIB 3006 Background: Talazoparib, a PARP inhibitor, is active in germline BRCA1/2 mutant advanced HER2-negative breast cancer, but its activity beyond BRCA1/2 is unknown. We conducted a single institution phase II trial to evaluate talazoparib in patients (pts) with advanced HER2-negative breast cancer or other solid tumors with a germline (g) or somatic (s) alteration in HR pathway genes not SAFETY AND CLINICAL ACTIVITY OF DURVALUMAB MONOTHERAPY IN 4071 Background: Durvalumab, an anti-PD-L1 mAb, has shown early and durable clinical activity with manageable safety in an ongoing Phase 1/2, multicenter, open-label study in pts with advanced solid tumors. Interim analyses from the HCC cohort in the dose-expansion part of this study are reported here. Methods: Patients with HCC (Child-Pugh class A) received durvalumab 10 mg/kg i.v. q2w for 12 MANAGEMENT OF IMMUNE-RELATED ADVERSE EVENTS IN PATIENTS Purpose To increase awareness, outline strategies, and offer guidance on the recommended management of immune-related adverse events in patients treated with immune checkpoint inhibitor (ICPi) therapy. Methods A multidisciplinary, multi-organizational panel of experts in medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, JOURNAL OF CLINICAL ONCOLOGY Journal of Clinical Oncology (JCO) is a high-impact, peer-reviewed medical journal that publishes significant clinical oncology research along with editorials, reviews, and other works that relate to the care of patients with cancer. KEYNOTE-355: RANDOMIZED, DOUBLE-BLIND, PHASE III STUDY OF 1000 Background: Pembrolizumab (pembro) monotherapy showed promising antitumor activity and manageable safety in patients (pts) with metastatic TNBC in KEYNOTE-012, -086 and -119. KEYNOTE-355 (ClinicalTrials.gov, NCT02819518) compared pembro + chemotherapy (chemo) vs placebo (pbo) + chemo for previously untreated locally recurrent inoperable or metastatic TNBC. Methods: Pts LAST HUG | JOURNAL OF CLINICAL ONCOLOGY DOI: 10.1200/JCO.21.00733 Journal of Clinical Oncology - published online before print June 10, 2021 PHASE II/III TRIAL OF POST-OPERATIVE CHEMORADIOTHERAPY 6502 Background: The standard treatment for post-operative high-risk patients (pts) with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) is chemoradiotherapy with 3-weekly cisplatin (CDDP) (100 mg/m2, q3wk, 66 Gy/33Fr; 3-weekly CDDP+RT). However, one concern with 3-weekly CDDP+RT is insufficient CDDP compliance due to high-dose-related toxicities. Weekly RESPONSE PREDICTION TO NEOADJUVANT SYSTEMIC TREATMENT IN Show More André Pfob, University Breast Unit, Department of Obstetrics and Gynecology, Heidelberg University Hospital, Heidelberg, Germany, MD Anderson Center for INSPiRED Cancer Care (Integrated Systems for Patient-Reported Data), The University of FINDING THE SWEET SPOT IN THE MANAGEMENT OF EARLY HER2 Show More 1 David Geffen School of Medicine, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA In this issue, Pernas and Tolaney 12 provide a sweeping, yet thorough overview of the management of HER2-positive breast cancer in the curative setting. Focusing NEXT-GENERATION IMPLEMENTATION OF CHIMERIC ANTIGEN Chimeric antigen receptor T-cell (CAR-T) therapy is a paradigm-shifting immunotherapy modality in oncology; however, unique toxicities such as cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome limit its ability to be implemented more widely in the outpatient setting or at smaller-volume centers. Three operational challenges with CAR-T therapy TAILORING THERAPY TO BE JUST RIGHT IN HER2-POSITIVE EARLY Show More 1 Department of Medicine, Memorial Sloan Kettering Cancer Center, Evelyn H. Lauder Breast Center, 300 East 66th Street, New York, NY All authors acknowledge support from the NCI Cancer Center Support Grant P30-CA008748. J.Z.D. acknowledges support from the Paul Calabresi Career Development REPLY TO A. PFOB ET AL W.T.T. received grant funding from the Tri-Council (CIHR) Government of Canada's New Frontiers in Research Fund (NFRF, Grant No. NFRFE-2019-00193), the Terry Fox Research Institute (TFRI, Grant No. 1083), and the Women's Health Golf Classic Foundation Fund. A.S.N.'slaboratory is
ADJUVANT TYROSINE KINASE INHIBITORS IN RENAL CELL PURPOSE Multiple large clinical trials have investigated adjuvant tyrosine kinase inhibitors (TKIs) to reduce the risk of cancer recurrence and progression to metastasis in high-risk renal cell carcinoma. We sought to maintain living and interactive evidence on this topic, until a high level of certainty is reached for key clinical outcomes such that further updates become unnecessary and CURRENT ISSUE TABLE OF CONTENTS American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options. Schnipper et al. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. Basch et al. JOURNAL OF CLINICAL ONCOLOGY Journal of Clinical Oncology (JCO) is a high-impact, peer-reviewed medical journal that publishes significant clinical oncology research along with editorials, reviews, and other works that relate to the care of patients with cancer.ASCO DAILY NEWS
ASCO Daily News is the official conference reporter of the American Society of Clinical Oncology (ASCO), providing high-quality, unbiased research summaries and oncology news to ASCO members and oncology health care providers. KEYNOTE-177: PHASE III RANDOMIZED STUDY OF PEMBROLIZUMAB 6 Background: KEYNOTE-177 (NCT02563002) evaluated the antitumor activity of pembrolizumab (pembro) vs chemotherapy ± bevacizumab or cetuximab (chemo) as first-line therapy for patients with microsatellite-instability high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC). We present results of the final PFS analysis and analysis of PFS2. Methods: Patients with PHASE II STUDY OF MAINTENANCE RUCAPARIB IN PATIENTS WITH PURPOSE Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi), is approved as maintenance therapy for patients with advanced pancreatic cancer (PC) and a germline BRCA1 or BRCA2 pathogenic variant (PV). This investigator-initiated, single-arm phase II study assessed the role of the PARPi rucaparib as maintenance therapy in advanced PC with germline or somatic PV in BRCA1, FIRST RESULTS FROM THE PHASE 3 CHECKMATE 274 TRIAL OF 391 Background: The standard of care (SOC) for patients (pts) with MIUC is radical surgery ± cisplatin-based neoadjuvant chemotherapy (chemo), but many pts are cisplatin-ineligible. There is no conclusive evidence supporting adjuvant chemo in pts who did not receive neoadjuvant chemo and in those with residual disease after neoadjuvant cisplatin. This phase 3 trial of adjuvant nivolumab (NIVO A PHASE 3, TRIAL OF GILTERITINIB, AS MAINTENANCE THERAPY TPS7075 Background: Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) mutations in acute myeloid leukemia (AML) are a common indication for allogeneic hematopoietic stem cell transplant (HSCT) in first complete remission (CR1). Despite HSCT, relapses are common and cure rates are limited thereafter. The use of FLT3 inhibitors as post-HSCT maintenance therapy has not been ECONOMIC IMPACT OF NEXT-GENERATION SEQUENCING VERSUS PURPOSE The aim of the current study was to assess the economic impact of using next-generation sequencing (NGS) versus single-gene testing strategies among patients with metastatic non–small-cell lung cancer (mNSCLC) from the perspective of the Centers for Medicare & Medicaid Services (CMS) and US commercial payers. METHODS A decision analytic model considered patients ADJUVANT CAPECITABINE FOR BILIARY TRACT CANCER: THE BILCAP 4006 Background: Despite improvements in multidisciplinary management, BTC has a poor outcome. Approximately 20% of cases are suitable for surgical resection with a 5 year survival of < 10%. BILCAP aimed to determine whether capecitabine (Cape) improves overall survival (OS) compared to observation (Obs) following radical surgery. Methods: Patients with completely-resected ANTIMICROBIAL PROPHYLAXIS FOR ADULT PATIENTS WITH CANCER JOURNAL OF CLINICAL ONCOLOGY ASCO SPECIAL ARTICLE Antimicrobial Prophylaxis for Adult Patients With Cancer-Related Immunosuppression: ASCO and IDSA Clinical Practice Guideline Update Randy A. Taplitz, Erin B. Kennedy, Eric J. Bow, Jennie Crews, Charise Gleason, Douglas K. Hawley, Amelia A. CURRENT ISSUE TABLE OF CONTENTS American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options. Schnipper et al. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. Basch et al. JOURNAL OF CLINICAL ONCOLOGY Journal of Clinical Oncology (JCO) is a high-impact, peer-reviewed medical journal that publishes significant clinical oncology research along with editorials, reviews, and other works that relate to the care of patients with cancer.ASCO DAILY NEWS
ASCO Daily News is the official conference reporter of the American Society of Clinical Oncology (ASCO), providing high-quality, unbiased research summaries and oncology news to ASCO members and oncology health care providers. KEYNOTE-177: PHASE III RANDOMIZED STUDY OF PEMBROLIZUMAB 6 Background: KEYNOTE-177 (NCT02563002) evaluated the antitumor activity of pembrolizumab (pembro) vs chemotherapy ± bevacizumab or cetuximab (chemo) as first-line therapy for patients with microsatellite-instability high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC). We present results of the final PFS analysis and analysis of PFS2. Methods: Patients with PHASE II STUDY OF MAINTENANCE RUCAPARIB IN PATIENTS WITH PURPOSE Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi), is approved as maintenance therapy for patients with advanced pancreatic cancer (PC) and a germline BRCA1 or BRCA2 pathogenic variant (PV). This investigator-initiated, single-arm phase II study assessed the role of the PARPi rucaparib as maintenance therapy in advanced PC with germline or somatic PV in BRCA1, FIRST RESULTS FROM THE PHASE 3 CHECKMATE 274 TRIAL OF 391 Background: The standard of care (SOC) for patients (pts) with MIUC is radical surgery ± cisplatin-based neoadjuvant chemotherapy (chemo), but many pts are cisplatin-ineligible. There is no conclusive evidence supporting adjuvant chemo in pts who did not receive neoadjuvant chemo and in those with residual disease after neoadjuvant cisplatin. This phase 3 trial of adjuvant nivolumab (NIVO A PHASE 3, TRIAL OF GILTERITINIB, AS MAINTENANCE THERAPY TPS7075 Background: Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) mutations in acute myeloid leukemia (AML) are a common indication for allogeneic hematopoietic stem cell transplant (HSCT) in first complete remission (CR1). Despite HSCT, relapses are common and cure rates are limited thereafter. The use of FLT3 inhibitors as post-HSCT maintenance therapy has not been ECONOMIC IMPACT OF NEXT-GENERATION SEQUENCING VERSUS PURPOSE The aim of the current study was to assess the economic impact of using next-generation sequencing (NGS) versus single-gene testing strategies among patients with metastatic non–small-cell lung cancer (mNSCLC) from the perspective of the Centers for Medicare & Medicaid Services (CMS) and US commercial payers. METHODS A decision analytic model considered patients ADJUVANT CAPECITABINE FOR BILIARY TRACT CANCER: THE BILCAP 4006 Background: Despite improvements in multidisciplinary management, BTC has a poor outcome. Approximately 20% of cases are suitable for surgical resection with a 5 year survival of < 10%. BILCAP aimed to determine whether capecitabine (Cape) improves overall survival (OS) compared to observation (Obs) following radical surgery. Methods: Patients with completely-resected ANTIMICROBIAL PROPHYLAXIS FOR ADULT PATIENTS WITH CANCER JOURNAL OF CLINICAL ONCOLOGY ASCO SPECIAL ARTICLE Antimicrobial Prophylaxis for Adult Patients With Cancer-Related Immunosuppression: ASCO and IDSA Clinical Practice Guideline Update Randy A. Taplitz, Erin B. Kennedy, Eric J. Bow, Jennie Crews, Charise Gleason, Douglas K. Hawley, Amelia A.ASCO PUBLICATIONS
ASCO’s publications—including the Society’s flagship publication, the Journal of Clinical Oncology—serve readers as the most credible, authoritative, peer-reviewed resources for significant clinical oncology research that informs the delivery of high-quality patient care across the globe. CURRENT ISSUE TABLE OF CONTENTS American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options. Schnipper et al. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. Basch et al. PRELIMINARY RESULTS OF THE ORGAN PRESERVATION OF RECTAL 4008 Background: Organ preservation (OP) with a watch and wait strategy (WW) and total neoadjuvant therapy (TNT) are new treatment paradigms for patients with locally advanced rectal cancer. The safety and efficacy of WW and of TNT have not been studied prospectively. Methods: Patients with MRI stage II and III rectal adenocarcinoma were randomized to 4 months of FOLFOX or CAPEOXCARDIO-ONCOLOGY
DOI: 10.1200/JCO.21.00971 Journal of Clinical Oncology - published online before print June 8, 2021 UPDATED STANDARDIZED DEFINITIONS FOR EFFICACY END POINTS PURPOSE The Standardized Definitions for Efficacy End Points (STEEP) criteria, established in 2007, provide standardized definitions of adjuvant breast cancer clinical trial end points. Given the evolution of breast cancer clinical trials and improvements in outcomes, a panel of experts reviewed the STEEP criteria to determine whether modifications are needed. METHODS We conducted systematic NAXITAMAB-BASED CHEMOIMMUNOTHERAPY FOR RESISTANT HIGH-RISK 10025 Background: Chemoresistant and relapsed disease are major obstacles to curing high-risk neuroblastoma (HR-NB). Anti-GD2 monoclonal antibody (MoAb) is effective in preventing relapse after remission but responses in relapsed or progressive disease (PD) are rare. We investigated the combination of humanized anti-GD2 MoAb naxitamab, (previously termed Hu3F8), irinotecan, STEREOTACTIC ABLATIVE RADIOTHERAPY IN OPERABLE STAGE I 8506 Background: We published a pooled analysis of 2 randomized trials (STARS/ROSEL) that compared lobectomy with mediastinal lymph node dissection (L-MLND) vs stereotactic ablative radiotherapy (SABR) in operable stage I NSCLC. There were no significant differences in disease progression but significantly higher 3-year overall survival (OS) in the SABR arm (95% vs 79%). Owing to concerns RETROSPECTIVE COHORT STUDY OF ESTROGEN RECEPTOR LOW 525 Background: Estrogen receptor (ER) positive breast cancer (BC) is a heterogeneous disease, with ongoing debate on the optimal cut off point for clinically relevant ER expression. Tumors harboring ≤10% ER expression are associated with poor outcomes. We used a real-world database to assess prognostic and predictive value of an alternative ER expression cut points. Methods: This OUT-OF-POCKET COSTS OF COMPLEMENTARY MEDICINE FOLLOWING PURPOSE: To determine household spending patterns on complementary medicine following cancer and the financial impact in a setting with universal health coverage. METHODS: Country-specific data from a multinational prospective cohort study, Association of Southeast Asian Nations Costs in Oncology Study, comprising 1,249 cancer survivors were included. Household costs of TARGETING TUMOR-REJECTION ANTIGENS IN MELANOMA WITH TUMOR The following represents disclosure information provided by the author of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject CURRENT ISSUE TABLE OF CONTENTS American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options. Schnipper et al. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. Basch et al. JOURNAL OF CLINICAL ONCOLOGY Journal of Clinical Oncology (JCO) is a high-impact, peer-reviewed medical journal that publishes significant clinical oncology research along with editorials, reviews, and other works that relate to the care of patients with cancer.ASCO DAILY NEWS
ASCO Daily News is the official conference reporter of the American Society of Clinical Oncology (ASCO), providing high-quality, unbiased research summaries and oncology news to ASCO members and oncology health care providers. KEYNOTE-177: PHASE III RANDOMIZED STUDY OF PEMBROLIZUMAB 6 Background: KEYNOTE-177 (NCT02563002) evaluated the antitumor activity of pembrolizumab (pembro) vs chemotherapy ± bevacizumab or cetuximab (chemo) as first-line therapy for patients with microsatellite-instability high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC). We present results of the final PFS analysis and analysis of PFS2. Methods: Patients with PHASE II STUDY OF MAINTENANCE RUCAPARIB IN PATIENTS WITH PURPOSE Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi), is approved as maintenance therapy for patients with advanced pancreatic cancer (PC) and a germline BRCA1 or BRCA2 pathogenic variant (PV). This investigator-initiated, single-arm phase II study assessed the role of the PARPi rucaparib as maintenance therapy in advanced PC with germline or somatic PV in BRCA1, FIRST RESULTS FROM THE PHASE 3 CHECKMATE 274 TRIAL OF 391 Background: The standard of care (SOC) for patients (pts) with MIUC is radical surgery ± cisplatin-based neoadjuvant chemotherapy (chemo), but many pts are cisplatin-ineligible. There is no conclusive evidence supporting adjuvant chemo in pts who did not receive neoadjuvant chemo and in those with residual disease after neoadjuvant cisplatin. This phase 3 trial of adjuvant nivolumab (NIVO A PHASE 3, TRIAL OF GILTERITINIB, AS MAINTENANCE THERAPY TPS7075 Background: Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) mutations in acute myeloid leukemia (AML) are a common indication for allogeneic hematopoietic stem cell transplant (HSCT) in first complete remission (CR1). Despite HSCT, relapses are common and cure rates are limited thereafter. The use of FLT3 inhibitors as post-HSCT maintenance therapy has not been ECONOMIC IMPACT OF NEXT-GENERATION SEQUENCING VERSUS PURPOSE The aim of the current study was to assess the economic impact of using next-generation sequencing (NGS) versus single-gene testing strategies among patients with metastatic non–small-cell lung cancer (mNSCLC) from the perspective of the Centers for Medicare & Medicaid Services (CMS) and US commercial payers. METHODS A decision analytic model considered patients ADJUVANT CAPECITABINE FOR BILIARY TRACT CANCER: THE BILCAP 4006 Background: Despite improvements in multidisciplinary management, BTC has a poor outcome. Approximately 20% of cases are suitable for surgical resection with a 5 year survival of < 10%. BILCAP aimed to determine whether capecitabine (Cape) improves overall survival (OS) compared to observation (Obs) following radical surgery. Methods: Patients with completely-resected ANTIMICROBIAL PROPHYLAXIS FOR ADULT PATIENTS WITH CANCER JOURNAL OF CLINICAL ONCOLOGY ASCO SPECIAL ARTICLE Antimicrobial Prophylaxis for Adult Patients With Cancer-Related Immunosuppression: ASCO and IDSA Clinical Practice Guideline Update Randy A. Taplitz, Erin B. Kennedy, Eric J. Bow, Jennie Crews, Charise Gleason, Douglas K. Hawley, Amelia A. CURRENT ISSUE TABLE OF CONTENTS American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options. Schnipper et al. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. Basch et al. JOURNAL OF CLINICAL ONCOLOGY Journal of Clinical Oncology (JCO) is a high-impact, peer-reviewed medical journal that publishes significant clinical oncology research along with editorials, reviews, and other works that relate to the care of patients with cancer.ASCO DAILY NEWS
ASCO Daily News is the official conference reporter of the American Society of Clinical Oncology (ASCO), providing high-quality, unbiased research summaries and oncology news to ASCO members and oncology health care providers. KEYNOTE-177: PHASE III RANDOMIZED STUDY OF PEMBROLIZUMAB 6 Background: KEYNOTE-177 (NCT02563002) evaluated the antitumor activity of pembrolizumab (pembro) vs chemotherapy ± bevacizumab or cetuximab (chemo) as first-line therapy for patients with microsatellite-instability high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC). We present results of the final PFS analysis and analysis of PFS2. Methods: Patients with PHASE II STUDY OF MAINTENANCE RUCAPARIB IN PATIENTS WITH PURPOSE Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi), is approved as maintenance therapy for patients with advanced pancreatic cancer (PC) and a germline BRCA1 or BRCA2 pathogenic variant (PV). This investigator-initiated, single-arm phase II study assessed the role of the PARPi rucaparib as maintenance therapy in advanced PC with germline or somatic PV in BRCA1, FIRST RESULTS FROM THE PHASE 3 CHECKMATE 274 TRIAL OF 391 Background: The standard of care (SOC) for patients (pts) with MIUC is radical surgery ± cisplatin-based neoadjuvant chemotherapy (chemo), but many pts are cisplatin-ineligible. There is no conclusive evidence supporting adjuvant chemo in pts who did not receive neoadjuvant chemo and in those with residual disease after neoadjuvant cisplatin. This phase 3 trial of adjuvant nivolumab (NIVO A PHASE 3, TRIAL OF GILTERITINIB, AS MAINTENANCE THERAPY TPS7075 Background: Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) mutations in acute myeloid leukemia (AML) are a common indication for allogeneic hematopoietic stem cell transplant (HSCT) in first complete remission (CR1). Despite HSCT, relapses are common and cure rates are limited thereafter. The use of FLT3 inhibitors as post-HSCT maintenance therapy has not been ECONOMIC IMPACT OF NEXT-GENERATION SEQUENCING VERSUS PURPOSE The aim of the current study was to assess the economic impact of using next-generation sequencing (NGS) versus single-gene testing strategies among patients with metastatic non–small-cell lung cancer (mNSCLC) from the perspective of the Centers for Medicare & Medicaid Services (CMS) and US commercial payers. METHODS A decision analytic model considered patients ADJUVANT CAPECITABINE FOR BILIARY TRACT CANCER: THE BILCAP 4006 Background: Despite improvements in multidisciplinary management, BTC has a poor outcome. Approximately 20% of cases are suitable for surgical resection with a 5 year survival of < 10%. BILCAP aimed to determine whether capecitabine (Cape) improves overall survival (OS) compared to observation (Obs) following radical surgery. Methods: Patients with completely-resected ANTIMICROBIAL PROPHYLAXIS FOR ADULT PATIENTS WITH CANCER JOURNAL OF CLINICAL ONCOLOGY ASCO SPECIAL ARTICLE Antimicrobial Prophylaxis for Adult Patients With Cancer-Related Immunosuppression: ASCO and IDSA Clinical Practice Guideline Update Randy A. Taplitz, Erin B. Kennedy, Eric J. Bow, Jennie Crews, Charise Gleason, Douglas K. Hawley, Amelia A.ASCO PUBLICATIONS
ASCO’s publications—including the Society’s flagship publication, the Journal of Clinical Oncology—serve readers as the most credible, authoritative, peer-reviewed resources for significant clinical oncology research that informs the delivery of high-quality patient care across the globe. CURRENT ISSUE TABLE OF CONTENTS American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options. Schnipper et al. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. Basch et al. PRELIMINARY RESULTS OF THE ORGAN PRESERVATION OF RECTAL 4008 Background: Organ preservation (OP) with a watch and wait strategy (WW) and total neoadjuvant therapy (TNT) are new treatment paradigms for patients with locally advanced rectal cancer. The safety and efficacy of WW and of TNT have not been studied prospectively. Methods: Patients with MRI stage II and III rectal adenocarcinoma were randomized to 4 months of FOLFOX or CAPEOXCARDIO-ONCOLOGY
DOI: 10.1200/JCO.21.00971 Journal of Clinical Oncology - published online before print June 8, 2021 UPDATED STANDARDIZED DEFINITIONS FOR EFFICACY END POINTS PURPOSE The Standardized Definitions for Efficacy End Points (STEEP) criteria, established in 2007, provide standardized definitions of adjuvant breast cancer clinical trial end points. Given the evolution of breast cancer clinical trials and improvements in outcomes, a panel of experts reviewed the STEEP criteria to determine whether modifications are needed. METHODS We conducted systematic NAXITAMAB-BASED CHEMOIMMUNOTHERAPY FOR RESISTANT HIGH-RISK 10025 Background: Chemoresistant and relapsed disease are major obstacles to curing high-risk neuroblastoma (HR-NB). Anti-GD2 monoclonal antibody (MoAb) is effective in preventing relapse after remission but responses in relapsed or progressive disease (PD) are rare. We investigated the combination of humanized anti-GD2 MoAb naxitamab, (previously termed Hu3F8), irinotecan, STEREOTACTIC ABLATIVE RADIOTHERAPY IN OPERABLE STAGE I 8506 Background: We published a pooled analysis of 2 randomized trials (STARS/ROSEL) that compared lobectomy with mediastinal lymph node dissection (L-MLND) vs stereotactic ablative radiotherapy (SABR) in operable stage I NSCLC. There were no significant differences in disease progression but significantly higher 3-year overall survival (OS) in the SABR arm (95% vs 79%). Owing to concerns RETROSPECTIVE COHORT STUDY OF ESTROGEN RECEPTOR LOW 525 Background: Estrogen receptor (ER) positive breast cancer (BC) is a heterogeneous disease, with ongoing debate on the optimal cut off point for clinically relevant ER expression. Tumors harboring ≤10% ER expression are associated with poor outcomes. We used a real-world database to assess prognostic and predictive value of an alternative ER expression cut points. Methods: This OUT-OF-POCKET COSTS OF COMPLEMENTARY MEDICINE FOLLOWING PURPOSE: To determine household spending patterns on complementary medicine following cancer and the financial impact in a setting with universal health coverage. METHODS: Country-specific data from a multinational prospective cohort study, Association of Southeast Asian Nations Costs in Oncology Study, comprising 1,249 cancer survivors were included. Household costs of TARGETING TUMOR-REJECTION ANTIGENS IN MELANOMA WITH TUMOR The following represents disclosure information provided by the author of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subjectCookie Notice
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