542P Growth modulation index (GMI) of larotrectinib versus prior systemic treatments for TRK fusion cancer patients

TPS593 Background: Improvements in systemic treatments for breast cancer patients has led to increasing rates of pathologic complete response (pCR). In addition, the identification of a pCR has been greatly improved with magnetic resonance imaging (MRI). In patients with a pCR, surgical resection of (part of) the original tumor area is performed to confirm the absence or presence of pCR and is not likely to contribute to locoregional control. With the MICRA trial (Minimally Invasive Complete Response Assessment) we aim to omit breast surgery in breast cancer patients achieving pathologic complete response (pCR) after neoadjuvant systemic therapy (NST) using biopsies, thus preventing overtreatment and improving quality of life. Methods: The MICRA trial is a multi-center observational prospective cohort study. In all breast cancer patients receiving NST, a marker is placed in the center of the tumor area before NST. 440 patients with radiologic complete response or partial response (0.1-2.0 cm residual contrast enhancement, ≥30% decrease in tumor size according to RECIST criteria) on contrast enhanced MRI will be included in the MICRA trial. Patients with hormone receptor positive, triple negative and Human Epidermal growth factor Receptor 2 tumors are eligible. After NST, 8 ultrasound-guided biopsies are obtained in the region surrounding the marker, while the patient is under general anesthesia. Immediately hereafter, breast surgery is performed and pathology results of the biopsies and resected specimens are compared. The primary endpoint is specificity of post-NST biopsies. In addition, sensitivity and positive and negative predictive value will be calculated. We will perform a multivariable analysis using data on MRI and ultrasound findings, pre-NST pathology parameters and post-NST biopsy results to determine what the most reliable method is to assess pCR and how many biopsies are needed for this purpose. Conclusion: With the MICRA-trial we aim to select a group of breast cancer patients in whom surgery of the breast after NST can be omitted, by predicting the presence of a pCR on biopsies. Clinical trial information: NTR6120.

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A phase II study on the efficacy and toxicity of cabozantinib in recurrent/metastatic salivary gland cancer patients.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.6529 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 6529-6529

Author(s):

Wim van Boxtel ◽

Maike Uijen ◽

Chantal Driessen ◽

Sjoert Pegge ◽

Stefan M. Willems ◽

...

Keyword(s):

Salivary Gland ◽

Cancer Patients ◽

Phase Ii ◽

Phase Ii Study ◽

Objective Response ◽

Salivary Gland Cancer ◽

Severe Toxicity ◽

Duct Carcinoma ◽

Systemic Treatments ◽

Grade 3

6529 A phase II study on the efficacy and toxicity of cabozantinib in recurrent/metastatic salivary gland cancer patients. Background: Because c-MET and VEGFR are often overexpressed in salivary gland cancer (SGC), this study evaluated the efficacy and safety of cabozantinib in recurrent/metastatic (R/M) SGC pts. Methods: A single center, single arm, phase II study was conducted. Immunohistochemical c-MET positive (H-score ≥10) R/M SGC pts were included in 3 cohorts: adenoid cystic carcinoma (ACC), salivary duct carcinoma (SDC), and other SGCs. Objective growth or complaints due to the disease were required before inclusion in the ACC and other SGC cohort. No prior systemic treatments were required. Pts started 60 mg cabozantinib tablets OD. Primary endpoint was the objective response rate (ORR). A Simon two-stage design was used. In case of ≥1 objective response in the first 9 pts/cohort, 8 additional pts would be included in the cohort. Results: In total 25 pts were included from Sep. 2018 until premature closure due to severe toxicity in Nov. 2019. Median age was 56 years (range 49-72), prior treatments included: primary tumor resection ( n=19), radiotherapy ≥50Gy ( n=24), systemic therapy ( n=10; adjuvant in 2 pts, palliative in 8 pts). Six pts had grade 3 ( n=4), grade 4 ( n=1), or grade 5 ( n=1) wound/fistula complications, occurring at a median of 7.2 mths on cabozantinib (range 2.1-12.8). This resulted in a severe wound complication rate of 32% in 19 pts on treatment for ≥2 mths. Remarkably, 4 out of 6 pts developed this complication in the area exposed to high-dose Rx; 2/4 had a pre-existing fistula in this area. Median interval between Rx and start of cabozantinib was 71.3 mths (range 10.6-94.7). Other grade ≥3 adverse events in >1 pt were: hypertension (5 pts), diarrhoea (2 pts) and dehydration (2 pts). Current median follow-up is 6.8 mths. The ORR was 6% (1/17 pts) in the ACC cohort, 20% (1/5 pts) in the SDC cohort, and 0% (0/3 pts) in other SGC pts; median PFS is 12.6 mths (95% CI 6.8 – 18.4 mths), 9.0 mths (insufficient events for 95% CI), and 6.9 mths (95% CI 0 – 15.2 mths), respectively. Median OS is not reached in any cohort. Conclusions: This phase II study on cabozantinib in R/M SGC pts demonstrated severe wound and fistula complications in 32% of pts on treatment for ≥2 mths, mostly (4/6 pts) within the radiotherapy field. Because of this toxicity the study was closed prematurely. Furthermore, cabozantinib showed minimal clinical activity in SGC pts. Research funding: Ipsen Pharmaceuticals Clinical trial information: NCT03729297 .

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How the COVID-19 Pandemic Impacted on Integrated Care Pathways for Lung Cancer: The Parallel Experience of a COVID-Spared and a COVID-Dedicated Center

Frontiers in Oncology ◽

10.3389/fonc.2021.669786 ◽

2021 ◽

Vol 11 ◽

Author(s):

Giulia Pasello ◽

Jessica Menis ◽

Sara Pilotto ◽

Stefano Frega ◽

Lorenzo Belluomini ◽

...

Keyword(s):

Lung Cancer ◽

Integrated Care ◽

Cancer Patients ◽

Early Stage ◽

Locally Advanced ◽

University Hospital ◽

Care Pathways ◽

Systemic Treatments ◽

Integrated Care Pathways ◽

The Impact

IntroductionThe COVID-19 pandemic has proved to be a historic challenge for healthcare systems, particularly with regard to cancer patients. So far, very limited data have been presented on the impact on integrated care pathways (ICPs).MethodsWe reviewed the ICPs of lung cancer patients who accessed the Veneto Institute of Oncology (IOV)/University Hospital of Padua (Center 1) and the University Hospital of Verona (Center 2) before and after the COVID-19 pandemic, through sixteen indicators chosen by the members of a multidisciplinary team (MDT).ResultsTwo window periods (March and April 2019 and 2020) were chosen for comparison. Endoscopic diagnostic procedures and major resections for early stage NSCLC patients increased at Center 1, where a priority pathway with dedicated personnel was established for cancer patients. A slight decrease was observed at Center 2 which became part of the COVID unit. Personnel shortage and different processing methods of tumor samples determined a slightly longer time for diagnostic pathway completion at both Centers. Personnel protection strategies led to a MDT reshape on a web basis and to a significant selection of cases to be discussed in both Centers. The optimization of patient access to healthcare units reduced first outpatient oncological visits, patient enrollment in clinical trials, and end-of-life cancer systemic treatments; finally, a higher proportion of hypofractionation was delivered as a radiotherapy approach for early stage and locally advanced NSCLC.ConclusionsBased on the experience of the two Centers, we identified the key steps in ICP that were impacted by the COVID-19 pandemic so as to proactively put in place a robust service provision of thoracic oncology.

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Systemic Treatments for Lung Cancer Patients Receiving Hemodialysis

Journal of the Advanced Practitioner in Oncology ◽

10.6004/jadpro.2018.9.6.4 ◽

2018 ◽

Vol 9 (6) ◽

Author(s):

Tzewah V. Leung, PharmD, BCOP ◽

Mitchell E. Hughes, PharmD, BCPS, BCOP ◽

Christine G. Cambareri, PharmD, BCPS, BCOP ◽

Daniel J. Rubin, PharmD ◽

Beth Eaby-Sandy, MSN, CRNP, OCN

Keyword(s):

Lung Cancer ◽

Cancer Patients ◽

Lung Cancer Patients ◽

Systemic Treatments

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Real Life Data on Patient-Reported Outcomes and Neuro-Cognitive Functioning of Lung Cancer Patients: The PRO-Long Study

Frontiers in Oncology ◽

10.3389/fonc.2021.685605 ◽

2021 ◽

Vol 11 ◽

Author(s):

Lotte Van Der Weijst ◽

Veerle Surmont ◽

Wim Schrauwen ◽

Yolande Lievens

Keyword(s):

Lung Cancer ◽

Cancer Patients ◽

Visual Memory ◽

Patient Reported Outcomes ◽

Post Treatment ◽

Lung Cancer Patients ◽

Systemic Treatments ◽

Patient Reported ◽

The Impact ◽

Over Time

IntroductionThis report investigates the impact of systemic treatments (chemotherapy or immunotherapy) with(out) loco-regional radiotherapy, on HRQoL, toxicity and neurocognitive functioning (NCF) in locally advanced and metastatic non-small cell lung cancer patients enrolled in the PRO-Long study.Materials and MethodsData on patient-reported HRQoL and fourteen toxicities was collected, while NCF was tested, up to one-year post-treatment. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer QLQ-C30. Lung cancer, treatment and neuro-psychological related toxicities were scored with the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. NCF was evaluated with six neurocognitive tests. Mixed model analyses were conducted to determine statistical significance (p = .01). Meaningful clinical important differences (MCIDs) were applied for changes in HRQoL and NCF data, while toxicities were compared to baseline values.ResultsIn total, 50 patients were enrolled. Overall HRQoL (p = .357) nor its domains (physical, p = .643; role, p = .069; emotional, p = .254; cognitive, p = 494; social, p = .735) changed significantly over time. Meaningful improvements in overall HRQoL were seen in 22, 38 and 39% and deteriorations in 22, 5 and 28% of patients at 2–3, 6 and 12 months respectively post-treatment. Overall toxicity (p = .007), lack of appetite (p = .001), nausea (p = .004) and dysphagia (p = .000) significantly decreased over time. Treatment caused acute toxicity, such as dyspnoea (45%) and memory problems (42%), but also alleviated pre-existing symptoms, including lack of appetite (32%), anxiety (29%) and depression (28%) at 2/3 months. The NCF domains of visual memory (p = .000) and cognitive processing speed (p = .000) showed significant improvements over time. In terms of MCIDs, at 2–3 months (18%) and 6 months (15%), verbal memory was particularly impacted; at 12 months, visual memory (18%) and executive function (18%) deteriorated primarily.ConclusionThe results suggest that therapy has no significant negative impact on overall HRQoL, its domains, and NCF. About one-third of patients reported a meaningful improved HRQoL at 1 year post-treatment. Treatment caused toxicity, but also alleviated pre-existing symptoms.

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