|
HERCEPTIN(trastuzumab) kit(二十六)
|
18.4 |
26.8 |
21.4 |
|
95% CI |
22, 30 |
17, 24 |
17, 29 |
13, 24 |
23, 33 |
18, 27 |
|
p‑value§ |
0.05 |
0.17 |
0.16 |
Data from Study5 suggest that the beneficial treatment effects were largely limited to patients with the highest level of HER2 protein overexpression (3+) (see Table 10).
Table 10: Treatment Effects in Study5 as a Function of HER2 Overexpression or Amplification
|
HER2 Assay Result |
Number of Patients
(N) |
Relative Risk* for Time to Disease Progression
(95% CI) |
Relative Risk * for Mortality
(95% CI) |
|
|
|
CTA 2+ or 3+ |
469 |
0.49 (0.40, 0.61) |
0.80 (0.64, 1.00) |
|
FISH (+) † |
325 |
0.44 (0.34, 0.57) |
0.70 (0.53, 0.91) |
|
FISH (−)† |
126 |
0.62 (0.42, 0.94) |
1.06 (0.70, 1.63) |
|
CTA 2+ |
120 |
0.76 (0.50, 1.15) |
1.26 (0.82, 1.94) |
|
FISH (+) |
32 |
0.54 (0.21, 1.35) |
1.31 (0.53, 3.27) |
|
FISH (–) |
83 |
0.77 (0.48, 1.25) |
1.11 (0.68, 1.82) |
|
CTA 3+ |
349 |
0.42 (0.33, 0.54) |
0.70 (0.51, 0.90) |
|
FISH (+) |
293 |
0.42 (0.32, 0.55) |
0.67 (0.51, 0.89) |
|
FISH (–) |
43 |
0.43 (0.20, 0.94) |
0.88 (0.39, 1.98) |
Previously Treated Metastatic Breast Cancer (Study 6)
Herceptin was studied as a single agent in a multicenter, open‑label, single‑arm clinical trial (Study6) in patients with HER2 overexpressing metastatic breast cancer who had relapsed following one or two prior chemotherapy regimens for metastatic disease. Of 222patients enrolled, 66% had received prior adjuvant chemotherapy, 68% had received two prior chemotherapy regimens for metastatic disease, and 25% had received prior myeloablative treatment with hematopoietic rescue. Patients were treated with a loading dose of 4mg/kg IV followed by weekly doses of Herceptin at 2mg/kg IV.
The ORR (complete response+partial response), as determined by an independent Response eva luation Committee, was 14%, with a 2% complete response rate and a 12% partial response rate. Complete responses were observed only in patients with disease limited to skin and lymph nodes. The overall response rate in patients whose tumors tested as CTA 3+ was 18% while in those that tested as CTA 2+, it was 6%.
14.3 Metastatic Gastric Cancer
The safety and efficacy of Herceptin in combination with cisplatin and a fluoropyrimidine (capecitabine or 5-fluorouracil) were studied in patients previously untreated for metastat |
