A randomized study of temozolomide or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors: A trial of the ECOG-ACRIN Cancer Research Group (E2211).

Kunz, Pamela L.; Catalano, Paul J.; Nimeiri, Halla; Fisher, George A.; Longacre, Teri A.; Suarez, Carlos J.; Yao, James C.; Kulke, Matthew H.; Hendifar, Andrew Eugene; Shanks, James C.; Shah, Manisha H.; Zalupski, Mark M.; Schmulbach, Edmond L.; Reidy, Diane Lauren; Strosberg, Jonathan R.; O’Dwyer, Peter J.; Benson, Al B.

doi:10.1200/jco.2015.33.15_suppl.tps4145

Cited by 46 publications

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“…Liver‐directed therapy also remains a key treatment modality for patients with hepatic‐dominant tumors. Table summarizes the main findings of randomized trials in patients with NETs …”

Section: Treatment Of Advanced Tumorsmentioning

confidence: 99%

“…Overall, temozolomide‐based studies have demonstrated objective response rates ranging from 33% to 70%, with the highest response rates reported in studies that combined temozolomide with capecitabine . Recently, an Eastern Cooperative Oncology Group‐sponsored, prospective, randomized, phase 2 trial investigated temozolomide alone versus temozolomide plus capecitabine in 144 patients with progressive G1/G2 pNETs. The combination of temozolomide and capecitabine was associated with a significantly improved PFS (median PFS, 14.4 months in the temozolomide arm vs 22.7 months in the temozolomide/capecitabine arm; hazard ratio, 0.58 [ P = .023]) and OS (median OS, 38 months in the temozolomide arm vs not reached in the temozolomide/capecitabine arm; hazard ratio, 0.41 [ P = .012]).…”

Section: Treatment Of Advanced Tumorsmentioning

confidence: 99%

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Gastroenteropancreatic Neuroendocrine Tumors

Cives

Strosberg

2018

CA A Cancer J Clinicians

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478

411

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Neuroendocrine tumors (NETs) are heterogeneous malignancies arising from the diffuse neuroendocrine system. They frequently originate in the gastroenteropancreatic (GEP) tract and the bronchopulmonary tree, and their incidence has steadily increased in the last 3 decades. Fundamental biologic and genomic differences underlie the clinical heterogeneity of NETs, and distinct molecular features characterize NETs of different grades and different primary sites. Although surgery remains the cornerstone of treatment for localized tumors, systemic treatment options for patients with metastatic NETs have expanded considerably. Somatostatin analogs have demonstrated both antisecretory and antitumor efficacy. Peptide receptor radionuclide therapy with lutetium‐177 dotatate (177Lu‐DOTATATE) has been approved for advanced GEP‐NETs. The antitumor activity of everolimus has been demonstrated across a wide spectrum of NETs, and the antiangiogenic agent sunitinib has been approved for pancreatic NETs (pNETs). Chemotherapy with temozolomide and capecitabine has recently demonstrated an unprecedented prolongation of progression‐free survival in a randomized trial of pNETs. Multiple retrospective series have reported the efficacy of liver‐directed therapies both for palliating symptoms of hormone excess and for controlling tumor growth. Telotristat, an oral inhibitor of tryptophan hydroxylase, has been shown to reduce diarrhea in patients with carcinoid syndrome. Defining the therapeutic algorithm and identifying biomarkers predictive of response to treatments are among the main priorities for the next decade of research in the NET field.

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“…Liver‐directed therapy also remains a key treatment modality for patients with hepatic‐dominant tumors. Table summarizes the main findings of randomized trials in patients with NETs …”

Section: Treatment Of Advanced Tumorsmentioning

confidence: 99%

Section: Treatment Of Advanced Tumorsmentioning

confidence: 99%

Gastroenteropancreatic Neuroendocrine Tumors

Cives

Strosberg

2018

CA A Cancer J Clinicians

Self Cite

478

411

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“…The capecitabine/temozolomide (CAPTEM) regimen has shown significant activity in neuroendocrine tumors (NETs), particularly in pancreatic NETs, for which objective radiographic response rates (ORRs) have ranged from roughly 30% to 70%. [1][2][3][4][5] A recent randomized phase II study sponsored by the ECOG compared CAPTEM with temozolomide monotherapy in 144 patients with advanced, progressive, low-and intermediate-grade pancreatic NETs. 2 The study showed a clinically and statistically significant improvement in progression-free survival (PFS) with the combination regimen, with a median PFS of 22.7 versus 14.4 months (hazard ratio [HR], 0.58; P5.023).…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Toxicity Analysis of Capecitabine and Temozolomide in Neuroendocrine Neoplasms

Al‐Toubah

Pellè

Valone

et al. 2022

Journal of the National Comprehensive Cancer Network

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Background: The capecitabine/temozolomide (CAPTEM) regimen has significant activity in advanced neuroendocrine tumors (NETs). Questions exist regarding activity in pancreatic versus nonpancreatic NETs, risk of opportunistic infections, long-term myelotoxicity, and safety of prolonged treatment duration. Analysis of large patient cohorts is needed for the evaluation of rare toxicities and assessment of risk factors. Methods: We conducted a retrospective study of all patients with advanced NETs seen at Moffitt Cancer Center between January 2008 and June 2019 who received treatment with CAPTEM. Results: A total of 462 patients were eligible. The objective radiographic response rate was 46%, and the disease control rate was 81%. Median progression-free survival (PFS) was 18 months (95% CI, 14.0–21.9 months) and median overall survival was 51 months (95% CI, 42.8–59.2 months): 62 months in well-differentiated NETs versus 14 months in poorly differentiated neuroendocrine carcinomas (P<.0001). Patients with primary pancreatic tumors had the highest partial response rates and longest median PFS. Incidences of grade 4 thrombocytopenia and neutropenia were 7% and 3%, respectively, and substantially higher in women than men (P=.02 and P=.004, respectively). Only 1 case (0.2%) of suspected Pneumocystis pneumonia (PCP) was observed in a patient receiving corticosteroids. Three patients developed myelodysplastic disease, all of whom had received prior peptide receptor radiotherapy (PRRT). There were no acute treatment-related deaths; 1 patient died 2 months after a thrombocytopenic bleed. Conclusions: The CAPTEM regimen is exceptionally safe. Efficacy is particularly robust in well-differentiated pancreatic NETs. Severe myelotoxicity is rare; the risk of grade 4 cytopenias is significantly increased in women, and therefore sex-based dosing should be considered. There were no cases of myelodysplastic syndromes, except among patients who had received PRRT, a known risk factor. The risk of PCP is negligible.

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“…A prospective phase II study assessed the activity of capecitabine (750 mg/m 2 PO BID D1-D14) plus temozolomide (150–200 PO QD mg/m 2 D10-D14) every 28 days in patients with well-differentiated NETs [ 39 ]. Of the 11 patients with pancreatic NETs, the ORR and DCR were 36 and 91%, respectively.…”

Section: Current Evidence For Chemotherapy In the Systemic Settingmentioning

confidence: 99%

Chemotherapy in Neuroendocrine Tumors

Das

Al‐Toubah

Strosberg

2021

Cancers

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The role for cytotoxic chemotherapy in patients with well-differentiated neuroendocrine tumors (NETs) remains debated. Compared to patients with poorly differentiated neuroendocrine carcinomas (NECs) where chemotherapy is utilized ubiquitously, chemotherapy may play a more select role in patients with certain types of NETs (e.g., pancreatic tumors, higher grade tumors, and tumors possessing DNA damage repair defects). The primary types of chemotherapy that have been tested in patients with NETs include alkylating agent- and platinum agent-based combinations. Across regimens, chemotherapy appears to elicit greater antitumor activity in patients with pancreatic or grade 3 NETs. The role for chemotherapy in lower grade extra-pancreatic NETs remains undefined. Furthermore, while chemotherapy has demonstrated clinically meaningful benefit for patients in the systemic setting, its role in the adjuvant or neoadjuvant setting is as-of-yet undetermined. Finally, efforts to combine chemotherapy with targeted therapy and peptide receptor radionuclide therapy are ongoing, in hopes of improving the cytoreductive treatment options for patients with NETs.

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A randomized study of temozolomide or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors: A trial of the ECOG-ACRIN Cancer Research Group (E2211).

Cited by 46 publications

References 0 publications

Gastroenteropancreatic Neuroendocrine Tumors

Gastroenteropancreatic Neuroendocrine Tumors

Efficacy and Toxicity Analysis of Capecitabine and Temozolomide in Neuroendocrine Neoplasms

Chemotherapy in Neuroendocrine Tumors

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