Publications by authors named "Charles Blanke"
Background: Anti-programmed death-1 (PD-1)/cytotoxic T lymphocyte antigen-4 antibodies are efficacious in various malignancies.
Objectives: This study presents the first results of ipilimumab-nivolumab in invasive mucinous or non-mucinous lepidic adenocarcinoma (invasive mucinous adenocarcinoma (IMA) or invasive non-mucinous lepidic adenocarcinomas (INLA), respectively) of the lung.
Design: Dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART) is a prospective, open-label, multicenter (1016 US sites), multi-cohort phase II trial of ipilimumab (1 mg/kg intravenously (IV) every 6 weeks) plus nivolumab (240 mg IV every 2 weeks).
Article Synopsis
- The SWOG S1609 DART trial investigated the effectiveness of dual therapy with ipilimumab and nivolumab in patients with vulvar cancers, showing initial promising results.
- In this phase II clinical trial involving 16 patients, the objective response rate was 18.8%, with some patients exhibiting durable responses and stable disease.
- Adverse effects were common, including diarrhea and fatigue, with 25% of patients experiencing severe side effects, highlighting the need for ongoing studies to identify response and resistance markers.
Article Synopsis
- The study assesses the effectiveness of a dual checkpoint inhibition therapy (ipilimumab and nivolumab) on advanced non-epithelial ovarian cancers (NEOCs) in patients who have no other effective treatments available.
- In a clinical trial involving 17 patients, the therapy showed a 25% overall response rate in those with granulosa cell tumors, with some patients experiencing significant progression-free survival and overall survival benefits.
- However, the therapy had serious side effects, leading to treatment discontinuation in 18% of participants and no positive responses noted in carcinosarcoma cases.
Article Synopsis
- Dual inhibition using ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1) was tested on patients with desmoid tumors in a phase II clinical trial to assess efficacy and safety in treating these rare solid tumors.
- The study involved 16 patients, with an overall response rate (ORR) of 18.8%, and a clinical benefit rate (CBR) of 62.5%, indicating decent stability and response to treatment over an average of 19.4 months of progression-free survival (PFS).
- Adverse events were common, with fatigue, nausea, and hypothyroidism reported, highlighting the need for careful monitoring during treatment.
Background: Plant-based diet is associated with better survival among patients with non-metastatic colorectal cancer (CRC), but its association in metastatic CRC is unknown.
Methods: Using an NCI-sponsored trial (CALGB/SWOG 80405), we included 1,284 patients who completed validated food frequency questionnaires at the initiation of metastatic CRC treatment. We calculated three indices: overall plant-based diet index (PDI), which emphasized consumption of all plant foods while reducing animal food intake; healthful plant-based diet index (hPDI), which emphasized consumption of healthful plant foods such as whole grains, fruits, and vegetables; and unhealthful plant-based diet index (uPDI), which emphasized consumption of less healthful plant foods such as fruit juices, refined grains, and sugar-sweetened beverages.
Objectives: Multiple common cancers benefit from immunotherapy; however, less is known about efficacy in rare tumors. We report the results of the adrenocortical carcinoma cohort of NCI/SWOG S1609 Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors.
Design/setting: A prospective, phase 2 clinical trial of ipilimumab plus nivolumab was conducted by the SWOG Early Therapeutics and Rare Cancers Committee for multiple rare tumor cohorts across >1,000 National Clinical Trial Network sites.
Introduction: Patients with high-risk resected gastrointestinal stromal tumors (GIST) receiving adjuvant imatinib have improved recurrence-free survival (RFS), however whether a complete cytocidal effect exists is unknown. We investigated this using a normalized recurrence timeline measured from end of oncologic treatment (EOOT), defined as the later of resection or end of adjuvant therapy.
Methods: We reviewed patients with resected high-risk GIST at our cancer center from 2003 to 2018.
Clinical trials are essential for advancing oncology treatment strategies and have contributed significantly to the decline in cancer mortality rates over the past decades. Traditional explanatory trials, focused on establishing intervention efficacy in ideal settings, often lack generalizability and may not reflect real-world patient care scenarios. Furthermore, increasing complexity in cancer clinical trial design has led to challenges such as protocol deviations, slow enrollment leading to lengthened durations of trial, and escalating costs.
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- * High gene expression was linked to improved progression-free survival (PFS) and overall survival (OS), with cetuximab showing a survival advantage over bevacizumab in patients with high expression levels, while the opposite was true for low expression levels.
- * The study concluded that tumor gene expression is both prognostic and predictive, suggesting that measuring this expression can help tailor treatment, with patients having low expression potentially benefiting more from bevacizumab therapy.
Introduction: Most patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors offer the possibility of a durable response with less toxicity. This prospective, multicenter, open-label study was designed to evaluate the anticancer activity of nivolumab plus ipilimumab in patients with advanced gallbladder cancer.
View Article and Find Full Text PDFPurpose: CALGB (Alliance)/SWOG 80405 was a randomized phase III trial that in first-line patients with metastatic colorectal cancer (mCRC) treated with bevacizumab or cetuximab with chemotherapy. We aimed to discover novel mutated genes associated with prognosis and differential response to therapy with the biologics.
Methods: Primary tumor DNA from 548 patients was sequenced using FoundationOne.
The National Cancer Institute recently found that death rates for non-small cell lung cancer (NSCLC) have been reduced by over 6% overall in recent years. This reduction in mortality has been accompanied by an average increase in overall survival and largely credited to the therapeutic advancements for the effective treatment of NSCLC. Numerous molecular alterations have been identified in NSCLC that have enabled the development of new drugs capable of targeting these changes and efficiently kill cancerous cells.
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- - The study focused on gastrointestinal stromal tumors (GISTs), which often have mutations in the KIT or PDGFRA proteins, making them targets for the drug imatinib mesylate.
- - Analysis of tumors from 127 patients revealed that 88.2% had KIT mutations (mostly in exons 9 and 11), with those having exon 11 mutations showing an 83.5% response rate to imatinib, while those with exon 9 mutations or no detectable mutations had lower response rates.
- - The findings highlight that the presence and type of mutations in KIT or PDGFRA are significant indicators of how well patients with GISTs might respond to imatinib treatment.
Purpose: The efficacy of immune checkpoint blockade in gestational trophoblastic neoplasia (GTN) remains uncertain. We report the results of the GTN cohort of SWOG S1609 dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART).
Patients And Methods: This prospective, open-label phase II trial evaluated ipilimumab plus nivolumab across multiple rare tumor cohorts, including GTN.
Purpose: Lung Cancer Master Protocol (Lung-MAP), a public-private partnership, established infrastructure for conducting a biomarker-driven master protocol in molecularly targeted therapies. We compared characteristics of patients enrolled in Lung-MAP with those of patients in advanced non-small-cell lung cancer (NSCLC) trials to examine if master protocols improve trial access.
Methods: We examined patients enrolled in Lung-MAP (2014-2020) according to sociodemographic characteristics.
Background: One in three patients with stage III colon cancer will experience tumor recurrence. It is uncertain whether physical activity during and after postoperative chemotherapy for stage III colon cancer improves overall survival after tumor recurrence.
Methods: A prospective cohort study nested within a randomized multicenter trial of patients initially diagnosed with stage III colon cancer who experienced tumor recurrence (N = 399) was conducted.
Basket, umbrella, and platform trial designs (master protocols) have emerged over the last decade to study precision medicine approaches in oncology. First-generation trials like NCI-MATCH (Molecular Analysis for Therapy Choice) have proven the principle that studying targeted therapies on a large scale is feasible both from the laboratory and clinical perspectives. However, single-agent targeted therapies have shown limited ability to control metastatic disease, despite careful matching of drug to target.
View Article and Find Full Text PDFPurpose: To assess whether higher plasma 25-hydroxyvitamin D [25(OH)D] is associated with improved outcomes in colon cancer and whether circulating inflammatory cytokines mediate such association.
Experimental Design: Plasma samples were collected from 1,437 patients with stage III colon cancer enrolled in a phase III randomized clinical trial (CALGB/SWOG 80702) from 2010 to 2015, who were followed until 2020. Cox regressions were used to examine associations between plasma 25(OH)D and disease-free survival (DFS), overall survival (OS), and time to recurrence (TTR).
A survey of clinical research professionals @SWOG indicate that 80% of clinical trial offices are understaffed. Addressing this is critical so progress for people with cancer continues. Read more about lessons learned in the #COVID19 pandemic and how it informs a path forward.
View Article and Find Full Text PDFBackground: SWOG 0809 is the only prospective study of adjuvant chemotherapy followed by chemoradiation focusing on margin status in patients with extrahepatic cholangiocarcinoma (EHCC) and gallbladder cancer (GBCA); however, the effects of adjuvant therapy by nodal status have never been reported in this population.
Methods: Patients with resected EHCC and GBCA, stage pT2-4, node-positive (N+) or margin-positive (R1) who completed four cycles of chemotherapy followed by radiotherapy were included. Cox regression was used to compare overall survival (OS), disease-free survival (DFS), local recurrence, and distant metastasis by nodal status.
Purpose: In the United States, the National Cancer Institute National Cancer Clinical Trials Network (NCTN) groups have conducted publicly funded oncology research for 50 years. The combined impact of all adult network group trials has never been systematically examined.
Methods: We identified randomized, phase III trials from the adult NCTN groups, reported from 1980 onward, with statistically significant findings for ≥ 1 clinical, time-dependent outcomes.
Purpose: We sought to evaluate the independent and interactive associations of planned treatment duration, celecoxib use, physical activity, body mass index (BMI), diabetes mellitus, and vitamin B6 with oxaliplatin-induced peripheral neuropathy (OIPN) among patients with stage III colon cancer enrolled in a clinical trial.
Methods: We conducted a prospective, observational study of 2,450 patients with stage III colon cancer enrolled in the CALGB/SWOG 80702 trial, randomly assigned to 6 versus 12 cycles of adjuvant fluorouracil, leucovorin, and oxaliplatin chemotherapy with or without 3 years of celecoxib. OIPN was reported using the Common Terminology Criteria for Adverse Events (CTCAE) during and following completion of chemotherapy and the FACT/GOG-NTX-13 15-17 months after random assignment.