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"Rocha, Flavio"
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Landmark Series: Immunotherapy and Targeted Therapy for Pancreatic Cancer
2021
Pancreatic cancer is one of the most aggressive gastrointestinal malignancies despite multimodality therapy. In the last several years, genomic studies have revealed that carcinogenesis is driven largely by key driver mutations that can be targeted for oncologic therapy. In addition, advances in cancer immunology have identified receptors and monoclonal antibodies that can be manipulated into harnessing the power of the host’s immune system for antitumor treatment. These strategies have generated a paradigm shift in the management of several cancer types, including those in the gastrointestinal tract. However, there are several complicating factors when translating the results to pancreatic cancer, including the dense, fibrotic stroma unique to this disease that may shield the cancer cells from both cytotoxic and immunologic agents. Although the majority of trials have been performed in the metastatic setting, this review will focus on both the historic studies that have defined this field as well as the emerging data arising from ongoing efforts to exploit newly discovered mutations and their druggable targets.
Journal Article
The VIPR-1 trial (Visualizing Ischemia in the Pancreatic Remnant): Assessing the role of intraoperative indocyanine green perfusion in predicting postoperative pancreatic leaks and fistulas: Protocol for a phase II clinical trial
by
Salgado-Garza, Gustavo
,
Willy, Annika
,
Rocha, Flavio G.
in
Biology and Life Sciences
,
Clinical trials
,
Clinical Trials, Phase II as Topic
2025
Surgery of the pancreas has come a long way since its inception; however, postoperative morbidity is still high. Pancreatic leaks and fistulas are common complications in patients undergoing surgery to remove the pancreas. Fistulas delay subsequent oncological care after surgery and prolong the hospital stay. Hypoperfusion of the pancreas has been proposed as one factor leading to fistulas. Indocyanine green (ICG) injection allows the surgeon to evaluate blood perfusion to tissue in real-time. This protocol describes a trial that aims to assess the effectiveness of intraoperative ICG metrics of the cut edge of the remnant pancreas to predict postoperative fistulas. A single group will participate in an observational, surgeon-blinded, phase II trial. ICG measurements of the cut edge of the pancreas will be recorded before reconstruction. International Study Group on Pancreatic Surgery criteria for pancreatic fistula will be used to define leaks and fistulas. The study objective is to analyze the correlation between ICG measurements and the development or absence of both biochemical leak and clinically relevant fistula formation. Currently, limited objective intraoperative predictors exist for predicting postoperative fistulas. Having a reliable predictive tool could decrease the healthcare burden posed by fistulas. The findings of this trial will provide conclusions on the usefulness of ICG measurements in predicting postoperative pancreatic fistulas and leaks. This clinical trial is registered in ClinicalTrials.gov with the ID NCT06084013. The current protocol version is v1.1.
Journal Article
Extreme oncoplasty: Expanding indications for breast conservation
by
Rocha, Flavio G.
,
Laskin, Ruby
,
Grumley, Janie
in
Breast cancer
,
Breast Carcinoma In Situ - pathology
,
Breast Carcinoma In Situ - surgery
2019
Presence of multiple lesions and/or tumor span ≥5 cm are traditional indications for mastectomy. Patient desire for breast conservation has increased the interest in extreme oncoplastic breast conserving surgery (EOBCS) to avoid mastectomy; however, perioperative outcomes in this population have not been well described.
This is an observational cohort of breast cancer patients with multiple lesions and disease span ≥5 cm who underwent EOBCS. Patient demographics, disease span, margin width, mastectomy and re-excision rates, and cosmesis were evaluated.
One hundred-eleven patients underwent EOBCS between 2012 and 2017. Eighty-two patients presented with multifocal or multicentric disease with an average of 3.2 lesions per breast spanning 57.1 ± 23.6 mm. Eighteen patients presented with unifocal tumors measuring an average of 67.6 mm (range 50–160 mm) on imaging. Eleven patients with an imaging size of <5 cm had a disease span ≥5 cm on final pathology. No tumor on ink occurred in 87 (78.3%) patients. Fifty-seven (51.4%) patients had additional surgery for inadequate margins. Fifteen (12.6%) patients elected to have mastectomy while 42 (37.8%) patients opted for re-excision. Good to excellent cosmetic results were reported in 95% of patients who ultimately achieved breast conservation. Recurrence rate was 1.1% in patients who completed EOBCS and adjuvant radiation therapy.
EOBCS can allow for breast conservation in patients who are traditionally counseled to undergo mastectomy. Although the re-excision rate was significant, most patients ultimately achieved breast conservation with adequate margins. Further study is warranted to determine the long-term oncologic outcomes of this approach.
•Oncoplastic surgery can allow patients with multiple lesions and/or large tumor span to avoid mastectomy.•Although re-excision rate may be high, most patients can achieve breast conservation.•Short-term oncologic and cosmetic results are favorable.
Journal Article
NEO-GAP: A Single-Arm, Phase II Feasibility Trial of Neoadjuvant Gemcitabine, Cisplatin, and Nab-Paclitaxel for Resectable, High-Risk Intrahepatic Cholangiocarcinoma
by
Cao, Hop S. Tran
,
Switchenko, Jeffrey M.
,
Cleary, Sean P.
in
Adverse events
,
Albumins
,
Antineoplastic Combined Chemotherapy Protocols
2023
Purpose
Most patients with intrahepatic cholangiocarcinoma (IHCC) develop recurrence after resection. Adjuvant capecitabine remains the standard of care for resected IHCC. A combination of gemcitabine, cisplatin, and nab-paclitaxel (GAP) was associated with a 45% response rate and 20% conversion rate among patients with unresectable biliary tract cancers. The aim of this study was to evaluate the feasibility of delivering GAP in the neoadjuvant setting for resectable, high-risk IHCC.
Methods
A multi-institutional, single-arm, phase II trial was conducted for patients with resectable, high-risk IHCC, defined as tumor size > 5 cm, multiple tumors, presence of radiographic major vascular invasion, or lymph node involvement. Patients received preoperative GAP (gemcitabine 800 mg/m
2
, cisplatin 25 mg/m
2
, and nab-paclitaxel 100 mg/m
2
on days 1 and 8 of a 21-day cycle) for a total of 4 cycles prior to an attempt at curative-intent surgical resection. The primary endpoint was completion of both preoperative chemotherapy and surgical resection. Secondary endpoints were adverse events, radiologic response, recurrence-free survival (RFS), and overall survival (OS).
Results
Thirty evaluable patients were enrolled. Median age was 60.5 years. Median follow-up for all patients was 17 months. Ten patients (33%) experienced grade ≥ 3 treatment-related adverse events, the most common being neutropenia and diarrhea; 50% required ≥ 1 dose reduction. The disease control rate was 90% (progressive disease: 10%, partial response: 23%, stable disease: 67%). There was zero treatment-related mortality. Twenty-two patients (73%, 90% CI 57–86;
p
= 0.008) completed all chemotherapy and surgery. Two patients (9%) who successfully underwent resection had minor postoperative complications. Median length of hospital stay was 4 days. Median RFS was 7.1 months. Median OS for the entire cohort was 24 months and was not reached in patients who underwent surgical resection.
Conclusion
Neoadjuvant treatment with gemcitabine, cisplatin, and nab-paclitaxel is feasible and safe prior to resection of intrahepatic cholangiocarcinoma and does not adversely impact perioperative outcomes.
Journal Article
Enhancing Time–Frequency Signal Analysis: Integrating Windowing with the Fractional Fourier Transform for Modern Applications
by
Rocha, Flávio
,
Silva, Maykon
,
Oliveira, Ricardo
in
Circuits and Systems
,
Communication
,
Data collection
2025
Applications based on sensor data collection, such as respiration and heartbeat monitoring, rely on accurate frequency-domain analysis. Fields such as digital communication and pattern recognition also rely on spectral analysis of sensor-derived data, often leveraging the Fourier Transform (FT) as a key tool. However, FT presents drawbacks, such as spectral leakage, which can be partially mitigated by applying window functions. For critical applications, though, window functions alone may not be enough for optimal performance. Recent studies have explored combining window functions with the Fractional Fourier Transform (FrFT) to enhance results, though success depends on the chosen window function. Among existing options, Nuttall windows offer high attenuation of side lobes, reducing spectral leakage but also presenting a wide main lobe, leading to signal distortion. In this article, we propose a new mathematical model combining Nuttall windows with FrFT. This model provides a closed-form expression, utilizing a parameter to control the main lobe width while maintaining reduced side lobe size, thereby enhancing adaptability for various sensor-based applications. Results show that adjusting the main lobe width using the FrFT expands Nuttall windows’ applications, such as in spectral analysis of respiratory signals, where it improves frequency recognition, as well as in Filtered-OFDM to address Out-of-Band Emission, offering an effective solution to one of the major challenges in ensuring spectral efficiency.
Journal Article