作者: Jerry L. Klein ; Aldo N. Serafini ; Alain Pecking ; Alan J. Fischman ; Alain Chetanneau ; John Bolton ; Bruce G. Wolff ; Richard Baum ; Diana K. Goroff ; Michael G. Hanna ; Herbert C. Hoover ; Ramaswamy Subramanian ; Gordon E. Wynant

PURPOSEThe study contained herein was undertaken to evaluate the accuracy of radiolabeled human monoclonal antibody, 88BV59H21-2V67-66 (88BV59 or HumaSPECT-Tc), in predicting disease resectability in presurgical subjects with recurrent, metastatic, or occult colorectal carcinoma.METHODSA total of 219 patients with disease visualized on computed tomographic scan (recurrent or metastatic disease) or with negative or equivocal computed tomographic scan and rising carcinoembryonic antigen serum levels (occult group) received technetium Tc99m-labeled 88BV59 intravenously. Planar and single photon emission computed tomograhic images were obtained 14 to 20 hours postinfusion, before surgery. The ability of computed tomographic and HumaSPECT-Tc imaging to define the extent of disease and to predict resectability was evaluated based on surgical and histopathologic results.RESULTSIn patients with recurrent or metastatic disease (170 evaluable patients), the accuracy of predicting nonresectability of disease was significantly greater (P < 0.001) for HumaSPECT-Tc than for computed tomography (60 vs 29 percent). Computed tomography understaged 41 percent of patients believed to have resectable disease compared with 27 percent for HumaSPECT-Tc (P < 0.001). In occult disease patients (29 computed tomographic and 28 HumaSPECT-Tc evaluable patients), the overall accuracy of predicting resectability/nonresectability was 6 percent for HumaSPECT-Tc compared with 24 percent from computed tomography. Administration of HumaSPECT-Tc had no effect on monoclonal antibody-based in vitro diagnostic assays. Only a single patient demonstrated an anti-antibody response (90 ng/ml) at nine weeks postinfusion.CONCLUSIONHumaSPECT-Tc was more accurate than computed tomography in determining disease resectability in patients with metastatic, recurrent, or occult cancer. The addition of HumaSPECT-Tc imaging can play a significant role in patient management decisions.

1998-05-01·Journal of Clinical Oncology1区 · 医学

Radioimmunoscintigraphy of recurrent, metastatic, or occult colorectal cancer with technetium 99m-labeled totally human monoclonal antibody 88BV59: results of pivotal, phase III multicenter studies.

1区 · 医学

Article

作者: A J Fischman ; J L Klein ; A N Serafini ; B G Wolff ; D K Goroff ; M G Hanna ; A Chetanneau ; R Subramanian ; A Pecking ; R Baum ; G E Wynant ; H C Hoover

PURPOSE To assess the performance and potential clinical impact of a totally human monoclonal antibody, 88BV59 (HumaSPECT) (INTRACEL, Corp, Rockville, MD), in 202 assessable presurgical patients with recurrent, metastatic, or occult colorectal cancer. METHODS 88BV59, labeled with technetium Tc 99m (99mTc) (HumaSPECT-Tc), was injected intravenously, and planar and single photon emission tomography (SPECT) images were obtained 14 to 20 hours postinjection. Surgical and pathologic verification of tumor were used as the standard against which the performance of HumaSPECT-Tc imaging and computed tomography (CT) analysis were evaluated. RESULTS All patients entered onto the recurrent disease study had at least one tumor site defined on CT. The sensitivity of HumaSPECT-Tc in those CT-positive patients was 87%. The specificity of HumaSPECT-Tc was 57% compared with 17% for CT and the difference was statistically significant (P < .001). The diagnostic information provided by HumaSPECT-Tc significantly (P < .001) improved the accuracy of the identification of resectable and nonresectable disease over that of CT (80% v 62%). HumaSPECT-Tc scans resulted in a significant (P < .001) reduction versus CT in terms of the proportion of patients understaged (27% v 41%) and overstaged (4% v 26%). In patients with occult disease (increasing carcinoembryonic antigen [CEA] titer, negative diagnostic work-up, negative CT), HumaSPECT-Tc correctly identified disease in 15 of 22 (68%) patients. HumaSPECT-Tc images provided additional clinical data that would have affected patient management decisions in 40 of 202 (19.8%) patients. In 365 patients who received 88BV59, only a single detectable human anti-human antibody (HAHA) response (90 ng/mL) at 9 weeks postinfusion was observed. CONCLUSION HumaSPECT-Tc can provide important and accurate information about the presence and location of disease in patients with a high clinical suspicion of metastatic or recurrent colorectal cancer and either positive (known disease) or negative (occult disease) CT scans.

100 项与伏妥莫单抗相关的药物交易

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