R. Quadro

Corewell Health Blodgett Hospital

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Paul O. Scheibe

Arroyo Grande Community Hospital

Robert C. Stadalnik

University of California, Davis

David R. Vera

University of California, San Diego

Muthukumar Subramanian

Boston Latin Academy

L. Muzikravic

Oncology Institute of Vojvodina

Colin Paul Spears

Mount Vernon Hospital

Kenneth A. Krohn

University Radiology

S Jelić

Oncology Institute of Vojvodina

Goran Janković

University of Belgrade

T. Reid

University of Virginia

Cooperative Institutions

Spectrum Health

University of California, Davis

Corewell Health Blodgett Hospital

University of California Davis Medical Center

Stanford University

University of California, San Diego

Oncology Institute of Vojvodina

University of California, Berkeley

University of Washington

University of California, Los Angeles

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5,10-methylenetetrahydrofolic acid with 5-fluorouracil as first line treatment in metastatic colorectal cancer: Phase II study results

Journal of Clinical Oncology (2006)

T. Reid Colin Paul Spears R. Quadro Muthukumar Subramanian L. Pawl

3599 Background: 5-Fluorouracil (FU) plus Leucovorin (LV) has historically been the standard first line treatment of colorectal cancer. Although LV modestly enhances FU activity, it can increase systemic toxicity and also must be intracellularly converted in multiple steps to its active metabolite, 5,10-methylenetetrahydrofolate (CoFactor [CO]). Unlike LV, CO directly modulates FU inhibition of thymidylate synthase without the need for metabolic conversion. Preclinical models show reduced hematologic toxicity of CO+FU with enhanced efficacy compared to FU+LV. We evaluated CO+FU chemotherapy in patients with previously untreated mCRC. Methods: Patients (pts) had performance status ECOG 0–2 and objectively measurable mCRC. Prior adjuvant therapy was allowed including FU+LV. Fifty pts were enrolled and treated with CO 60mg/m 2 and FU 450mg/m 2 (weekly IV bolus) for 6 weeks, followed by 14 day rest. Response was measured at 16 wks (WHO criteria). Results: As of January 2006, 50 pts received at least 1 dose of drug and are no longer on treatment. Patient demographics: median age = 65 (range 42–86), M/F = 60%/40%. Mean number of doses was 18.0 (range 2–41). Overall incidence of grade 3/4 AEs was 14 (28%). No grade 3/4 drug-related hematologic toxicity was observed. There was no significant effect on HCT, Bili, WBC, ALT, and AST during the course of the study. Objective response rate (CR + PR) to first line treatment with CO+FU based on independent blinded review was 35% (2 CR, 14 PR, 23 SD, 7 PD; 95% CI: 21.4–50.2) based on 46 pts evaluable for response. Median time to tumor progression was 163 days (95% CI: 105 -189). Twenty pts are deceased and median survival has not been reached. Conclusions: The results suggest thatCO+FU is safe, well tolerated, and has activity in mCRC. In the optimum treatment strategy afforded by the availability of numerous drugs, the high level of activity and low toxicity of CO+FU suggests that this combination may be a good initial treatment in a sequential strategy of mCRC management, especially among pts who would benefit by minimizing initial toxicity. [Table: see text]

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Active metabolite

10.1200/jco.2006.24.18_suppl.3599

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TC-99M GALACTOSYL-NEOGLYCOALBUMIN (TC-NGA)

Clinical Nuclear Medicine (1983)

Robert C. Stadalnik David R. Vera Lois F. O Grady R. Quadro Paul O. Scheibe

Stadalnik, Robert C.; Vera, David R.; O'Grady, Lois F.; Quadro, Robert E.; Scheibe, Paul O.; Krohn, Kenneth A.; Hutak, Dusan P. Author Information

10.1097/00003072-198309001-00016

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TC-99M GALACTOSYL-NEOGLYCOALBUMIN (TC-NGA): A PREDICTOR OF FUNCTIONING HEPATOCYTE MASS.

Clinical Nuclear Medicine (1983)

Robert C. Stadalnik David R. Vera L.F. O'Grady R. Quadro Paul O. Scheibe

Stadalnik, Robert C.; Vera, David R.; O'Grady, Lois F.; Quadro, Robert E.; Scheibe, Paul O.; Krohn, Kenneth A.; Hutak, Dusan P. Author Information

10.1097/00003072-198309009-00016

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Measuring functioning hepatocytes using Tc-99m galactosylneoglycoalbumin (Tc-NGA)

Journal of Nuclear Medicine (1984)

Robert C. Stadalnik David R. Vera R. Quadro K.A. Krohn Paul O. Scheibe

Tc-NGA is a synthetic ligand which binds only to hepatic binding protein (HBP), a receptor found only in the liver. It exhibits the properties of high tissue specificity, affinity-dependent uptake, and dose-dependent uptake. Tc-NGA provides an opportunity to study the functioning hepatocyte. The authors evaluated the usefulness of this technique in patients with hepatitis and hepatoma. After intravenous administration of 5 mCi Tc-NGA, dynamic images were acquired for 30 minutes followed by static views. Estimates of HBP concentrations were obtained by kinetic analysis of blood and liver time-activity curves. Kinetic estimates (reduced chi-squares < 3.0) of HBP correlated well with the clinical course and histology. For example, a patient with hepatoma whose calculated receptor population (functioning hepatocytes) was 3.0 +- 0.9 x 10/sup -7/ mole, which is the normal range, is doing well undergoing chemotherapy. Liver biopsy demonstrated normal liver tissue except for the hepatoma. Another patient with hepatoma who had a severely depressed receptor population, 1.2 +- 0.2 x 10/sup -8/ mole, expired one week after the study. Liver biopsy demonstrated practically no normal tissue. Thus, by means of a complementary, receptor radiopharmaceutical and mathematical model, one should be able to quantitatively follow hepatocyte function and predict response tomore » a therapeutic regimen.« less

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A Simon 2 stage study of 5,10 methylenetetrahydrofolic acid (CO) with 5-fluorouracil (FU) as first line treatment in metastatic colorectal cancer (mCRC)

Journal of Clinical Oncology (2005)

T. Reid Colin Paul Spears R. Quadro Muthukumar Subramanian L. Pawl

3692 Background: We are conducting an open label, Simon 2 stage study to assess the safety and efficacy of CO+FU for first line treatment in mCRC. Unlike leucovorin (LV), CO directly modulates FU inhibition of thymidine synthase without the need for metabolic conversion. Preclinical models show reduced hematologic toxicity of CO+FU with enhanced efficacy compared to FU+LV. Methods: Eligible patients (pts), age ≥18 with ECOG 0–2 and measurable mCRC, w/wo adjuvant FU+LV, irinotecan, or oxaliplatin, but no prior chemotherapy for mCRC. Pts received ≥2 cycles each consisting of CO 60mg/m2 and FU 450mg/m2 (weekly IV bolus) for 6 weeks, followed by 14 day rest. Pre-established response criteria is ≥4 of 23 for stage 1, ≥12 of 48 for stage 2. Response is defined as complete response (CR, complete disappearance), partial response (PR, ≥50% reduction in total tumor size), stable disease (SD, ≤50% reduction), progressive disease (PD, ≥25% increase) at week 16. Results: Safety data is available for 30 pts, median age 65.5 (range 42–86), F=53.3%, mean number of doses 10.2 (range 1–24). Overall incidence of grade 3/4 AEs was 2(6.6%, bowel obstruction, malignant pleural effusion). No grade 3/4 blood toxicity was observed. Response data is available for 12 pts: 3 PR, 6 SD, 3 PD. Conclusions: CO+FU has been well tolerated. The remaining pts are expected to be enrolled and data will be reported at the meeting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Adventrx Adventrx

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10.1200/jco.2005.23.16_suppl.3692

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Citations (2)

Epirubicin in non-oat cell lung cancer--response rates and the importance of immunopathology: a Northern California Oncology Group Study.

PubMed (1986)

Frederick J. Meyers Robert D. Cardiff R. Quadro M Gribble M. Kohler

Epirubicin

Oat cell carcinoma

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Citations (12)