scholarly journals Metastatic Malignant Paraganglioma Presenting as a Neck Mass Treated with Radiolabeled Somatostatin Analog

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Waqas Jehangir ◽  
Alexander Karabachev ◽  
Jackie Tsao ◽  
Christopher J. Anker ◽  
Sree Susmitha Garapati ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Survival Benefit ◽  
Randomized Clinical Trials ◽  
Tumor Response ◽  
Neck Mass ◽  
Tumor Burden ◽  
Alternative Therapies ◽  
Somatostatin Analog ◽  
Malignant Paraganglioma ◽  
Radiolabeled Somatostatin Analog

Paragangliomas are rare neuroendocrine tumors that arise from chromaffin-containing tissue. Surgical resection and/or radiation are used for locoregional disease, and reduction of tumor burden with systemic therapy is reserved for metastatic disease. Iobenguane I-131, somatostatin analog (octreotide), and Sunitinib are noncytotoxic options for treatment, while cyclophosphamide, vincristine, and dacarbazine (CVD) and temozolomide are often used as initial chemotherapy options as studies have shown that they offer some tumor response. However, there are no randomized clinical trials demonstrating prolonged survival with the use of chemotherapeutics in metastatic cases. Investigation of alternative therapies that provide survival benefit is thus necessary. We present a case of a 69-year-old female with metastatic malignant paraganglioma presenting as a left parapharyngeal neck mass, which metastasized after surgery, requiring radiation therapy for bony metastasis who was treated with a radioisotope somatostatin analog for disease progression.

Meta-analysis of randomized trials testing the biochemical modulation of fluorouracil by methotrexate in metastatic colorectal cancer. Advanced Colorectal Cancer Meta-Analysis Project.

1994 ◽  
Vol 12 (5) ◽  
pp. 960-969 ◽  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
Regression Model ◽  
Randomized Clinical Trials ◽  
Tumor Response ◽  
Advanced Colorectal Cancer ◽  
Response Rate ◽  
Meta Analysis ◽  
Biochemical Modulation

PURPOSE Even though fluorouracil (5FU) remains the standard treatment of advanced colorectal cancer, almost 90% of patients treated with 5FU alone do not achieve an objective response to chemotherapy. Biochemical modulation of 5FU by methotrexate (MTX) is an attempt to increase the sensitivity of tumor cells to 5FU. However, despite the inclusion of several hundreds of patients in randomized clinical trials, no definitive evidence is available on the clinical benefit of 5FU/MTX over 5FU alone. A meta-analysis was performed to assess this benefit objectively and quantitatively for tumor response rate and overall survival. DESIGN The meta-analysis was based on individual data of 1,178 patients included in eight randomized clinical trials comparing 5FU alone with 5FU/MTX. Patient data were provided by all principal investigators. The analyses were performed by an independent secretariat, and then discussed with all collaborators. RESULTS Tumor response rate was 10% for patients allocated to 5FU alone (complete response [CR] rate, 2%; partial response [PR] rate, 8%) compared with 19% for patients allocated to 5FU/MTX (CR rate, 3%; PR rate, 16%). This difference was highly significant, with an overall response odds ratio (OR) of 0.51 (95% confidence interval [CI], 0.37 to 0.70) (P < .0001). Median overall survival times were 9.1 months and 10.7 months in the 5FU-alone and 5FU/MTX groups, respectively. This difference was also statistically significant, with an overall survival OR of 0.87 (95% CI, 0.77 to 0.98) (P = .024). Logistic regression model and Cox regression model showed that performance status and randomized treatment were the only two significant predictors of tumor response and survival. CONCLUSION It is concluded that the modulation of 5FU by MTX doubles the response rate to 5FU, and yields a small improvement in survival.

Conversion to resectability in unresectable metastatic colorectal cancer chemotherapy (mCRC) trials.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 641-641
Author(s):  
Sarah Chrabaszcz ◽  
Rahul Rajeev ◽  
Brittany Klooster ◽  
Ashley Chinn ◽  
T. Clark Gamblin ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Survival Benefit ◽  
Randomized Clinical Trials ◽  
Study Groups ◽  
Dose Effect ◽  
Entire Cohort ◽  
Multiple Observations ◽  
Survival Difference ◽  
Overall Survival Benefit

641 Background: Patients with mCRC undergoing surgical metastasectomy have been shown to derive significant survival benefit with a potential for cure. We hypothesized that conversion to resectability (c2r) is correlated with increased overall survival in patients with unresectable mCRC. Methods: Prospectively registered systematic review (PROSPERO CRD42015024104) was utilized to identify randomized clinical trials published after 2003. Exposure of interest was c2r from unresectable disease, while the outcome was overall survival (OS). Clinical trials were classified into three groups based on difference in c2r between the two study groups ( < 2, 2-2.9, ≥ 3 %). Generalized estimating equations(GEE) were used to measure associations while adjusting for multiple observations from the same trial. The Cochrane risk of bias tool was used to evaluate the methodological quality. Results: Out of 2,902 studies reviewed, 30 satisfied selection criteria (n = 13,618 patients). All studies had two arms only (100%). Median c2r was 7.3% (Interquartile Range 5%-12.9%), with maximum c2r in FOLFOX/FOLFIRI+ cetuximab arm (28.6%). The median difference in c2r between two arms of the same study was 2.3% (IQR 1.3 – 3.4%) and the maximum difference was 15.4% seen in FOLFOX/FOLFIRI+ cetuximab vs. FOLFOX/FOLFIRI (Ye, 2013). Median OS for the entire cohort of patients was 20.7 months (IQR 18.9 – 22.7 months), with a between group difference of 1.3 (IQR -1.2 – 3.6 months). The maximum survival benefit between two study arms was 9.9 months. Median survival difference between the two study arms with a minimal c2r difference ( < 2%) was 0.8 months, as compared to 1.6 months with higher c2r ( ≥ 3%). Incremental dose effect response was noted with an increasing c2r leading to improved overall survival in regression models (p = 0.021, r2= 0.16). Higher response rates also correlated with higher c2r rates (p = 0.003, r2= 0.25). Conclusions: Conversion to resectability is positively correlated with an improvement in survival in trials examining therapies for unresectable mCRC. Patient level data examining the contribution of metastasectomy to the overall survival benefit of systemic chemotherapy needs to be further examined.

Target versus non-target lesions in determining disease progression: Analysis of 581 patients.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18053-e18053
Author(s):  
Stephen Raskin ◽  
Eyal Klang ◽  
Tehila Kharizman ◽  
Eli Konen ◽  
Raanan Berger ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Tumor Response ◽  
Objective Assessment ◽  
Objective Response ◽  
Subjective Assessment ◽  
Response To Therapy ◽  
Recist 1.1 ◽  
The Status ◽  
Mri Scans

e18053 Background: RECIST, among methodologies designed to provide an objective assessment of tumor response to therapy, is based on the measurement of Target Lesions (TLs) and classification of response according to an objective scale of beneficial response or progressive disease (PD). The “PD point” (the time-point at which RECIST 1.1 first classifies the trial as PD) is a common end-point in clinical trials and is defined as that point when the objective response rate is > 20%. However, RECIST also allows for the subjective assessment of non-TL lesions (NTLs) and new lesions (NLs) to determine the PD point. We sought to determine which of these parameters was most influential in determining PD. Methods: We evaluated the formal RECIST 1.1 assessments for consecutive patient enrollments in randomized clinical trials prepared by two senior radiologists at our institution from 2013 through 2018. Data was evaluated at the “PD point.” Results: There were 1260 patients, with 4499 CT or MRI scans. Of these, 581 trials concluded with PD. There were seven groups (+/-/-, -/+/-, -/-/+ . . . +/+/+) according to the status of TLs, NTLs, and NLs at the PD point. In 538 patients (92.6%), TLs were unnecessary in determining the PD point. Two-thirds of these had objective response rates of < 40%. Measurable and non-measurable NTLs were equally responsible for PD, and the strongest determinant of PD was the unequivocal appearance of new lesions. Conclusions: In this study, subjective parameters, as defined by RECIST 1.1, were far more likely to result in a determination of PD than objective ones. These findings may have relevance for considering the value of RECIST 1.1 as a scientific standard for therapeutic efficacy as well as in the design of new methodologies for the assessment of tumor response.

A template for generic asssessment of tumor response: "myRECIST".

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14149-e14149
Author(s):  
Stephen Raskin ◽  
Tehila Kharizman ◽  
Tatyana Rachutin Zalogin ◽  
Aliza Ackerstein ◽  
Eli Konen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Lymph Nodes ◽  
Randomized Clinical Trials ◽  
Tumor Response ◽  
Evaluation Criteria ◽  
Response To Therapy ◽  
Limited Sample ◽  
Recist 1.1 ◽  
Wide Range ◽  
Practice Methods

e14149 Background: Oncologists often need an objective, quantitative assessment of a patient's response to therapy. Lacking a standardized format, the oncologist may request a RECIST (Response Evaluation Criteria in Solid Tumors) analysis. RECIST, however, was developed to provide standardized assessment in the context of randomized clinical trials. RECIST is based on the prospective analysis of a limited sample of tumor lesions or lymph nodes, whereas the clinician naturally makes clinical decisions retrospectively. Furthermore, RECIST has definitions, rules, and criteria for classifying responses that may not apply in the clinical setting, and it does not include consistent rules for merging or splitting lymph nodes, mixed tumor responses, lesions that may cavitate, and a wide range of individualistic responses encountered in clinical practice. Methods: To address these issues, we have modified our working Excel-based template for RECIST 1.1 assessment to include a "myRECIST" feature, so that the radiologist can enter data and examine a range of pre-defined or customizable scenarios, including RECIST1.1, iRECIST, Lugano, volumetric and other parametric protocols. With a few interactions, this template can produce exportable tables and graphs of tumor responses that can guide therapy, as shown in the attached image. Definitions are standardized and linked to RADLEX ontology for specificity and subsequent analysis. Results: This template has been developed for clinical use and is available for downloading from our institutional web-site. Conclusions: We have developed, for public use, a free, easy-to-use, down-loadable Excel template for evaluating prospective or retrospective scenarios of tumor response to therapy that avoids the restrictions of the RECIST methodology. This template may prove useful to oncologists both in and out of the context of randomized clinical trials. We call this "myRECIST."

Cyclophosphamide plus cisplatin versus cyclophosphamide, doxorubicin, and cisplatin chemotherapy of ovarian carcinoma: a meta-analysis. The Ovarian Cancer Meta-Analysis Project.

1991 ◽  
Vol 9 (9) ◽  
pp. 1668-1674 ◽  
Keyword(s):  
Ovarian Cancer ◽  
Clinical Trials ◽  
Ovarian Carcinoma ◽  
Survival Benefit ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Dose Intensity ◽  
Second Look ◽  
Survival Difference ◽  
Significant Survival

Four randomized clinical trials comparing cyclophosphamide plus cisplatin (CP) versus cyclophosphamide, doxorubicin, and cisplatin (CAP) individually failed to show a significant survival difference in the treatment of ovarian carcinoma. However, by pooling 1,194 patients from these trials in a meta-analysis, there is a statistically significant survival benefit for CAP (P = .02); in addition, there is a significant advantage for CAP in frequency of negative second-look laparotomy (CAP, 30%; CP, 23%; P = .01). Because the dose intensity of CAP was greater than CP in three of the trials, it remains unresolved to what extent the benefit of CAP is from greater dose intensity and to what extent it is from the doxorubicin itself. Either interpretation suggests directions for improving the chemotherapy of ovarian carcinoma.

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