Lani
06-06-2008, 09:51 AM
Trastuzumab Treatment Extends Time to Progression in HER-2 Positive, Locally Advanced or Metastatic Breast Cancer, Even After Disease Progresses: Presented at ASCO
CHICAGO — June 5, 2008 — Continuation of treatment with trastuzumab in women with human epidermal growth factor receptor (HER2)-positive, locally advanced or metastatic breast cancer achieve extended time to disease progression, even when their disease has progressed while taking the drug.
In a phase 3 study, doctors found that patients who stopped trastuzumab but continued on treatment with capecitabine had overall time to progression of 5.6 months, but it was 8.2 months if they maintained treatment with trastuzumab.
The study, conducted by the German Breast Group, enrolled women with HER2-positive locally advanced or metastatic breast cancer who had previously received trastuzumab with or without chemotherapy as first-line treatment.
They were randomly assigned to receive trastuzumab at a dose of 6 mg/kg every 3 weeks with oral capecitabine at a dose of 2500 mg/m2 on days 1 to 14 every 21 days or capecitabine treatment alone. The final analysis included 156 patients.
"It is rewarding to see that trastuzumab keeps working in women whose aggressive HER2-positive breast cancer progresses," said Gunter von Minckwitz, MD, PhD, University Women's Hospital and German Breast Group, Frankfurt, Germany.
"The GBG-26 study results confirm that trastuzumab continues to target and shrink the cancer even beyond progression when combined with another chemotherapy [agent]," Dr. von Minckwitz said.
ASCO 2008: ABSTRACT #1025: Capecitabine vs. capecitabine + trastuzumab in patients with HER2-positive metastatic breast cancer progressing during trastuzumab treatment: The TBP phase III study (GBG 26/BIG 3-05)
American Society of Clinical Oncology
Background: There is uncertainty, if trastuzumab treatment should be continued beyond progression (TBP).
Methods: Patients (pts) with HER-2 positive, locally advanced or metastatic breast cancer that progressed during treatment with trastuzumab with or without adjuvant and/or 1st-line metastatic chemotherapy were prospectively randomized to capecitabine (X; 2,500 mg/m2 on days 1-14, q21) or X plus continuation of trastuzumab (XH; 6 mg/kg, q3w). The primary end point was TTP. With registration of lapatinib, the slowly accruing trial was closed prematurely.
Results: Between 01/04 and 05/07 156 pts (X=78; XH=78) were randomized and stratified according to pre-treatment: taxane/trastuzumab as 1st-line therapy (111 pts), taxanes/trastuzumab as adjuvant therapy (3 pts), trastuzumab alone or without taxanes as 1st-line treatment (42 pts). 75 (48.1%) pts were pre-treated with anthracyclines. 119 (76.3%) showed visceral metastasis. Current analysis (median follow-up 11.8 months) revealed a progression-free survival of 5.6 months with 53 events for X and 8.5 months with 48 events for XH (HR=0.71). Brain metastases were observed in 4 (X) and 7 (XH) pts. Overall survival was 19.9 months with 31 events for X and 20.3 months with 26 events in XH (HR=0.79). Crude response rates were 24.6% (X) and 49.1% (XH) and primary progressions were observed in 26.3% (X) and 16% (XH) of patients. Grade III/IV toxicities were (%X/%XH): neutropenia (3.3/6.3), febrile neutropenia (0/0), vomiting (6.0/1.6), diarrhea (20.9/14.8), mucositis (3.0/1.6), hand-foot syndrome (23.9/31.1), nail changes (0/4.9), sensory neuropathy (4.5/3.3), fatigue (6.0/4.9), allergic (3.0/3.3), and cardiac (2.9/4.9). No therapy-related death occurred.
Conclusions: Preliminary results of the TBP study suggest a higher efficacy but similar toxicity for continuing trastuzumab beyond trastuzumab progression when 2nd-line chemotherapy with capecitabine is initiated. Final efficacy analysis will be performed in March 2008.
CHICAGO — June 5, 2008 — Continuation of treatment with trastuzumab in women with human epidermal growth factor receptor (HER2)-positive, locally advanced or metastatic breast cancer achieve extended time to disease progression, even when their disease has progressed while taking the drug.
In a phase 3 study, doctors found that patients who stopped trastuzumab but continued on treatment with capecitabine had overall time to progression of 5.6 months, but it was 8.2 months if they maintained treatment with trastuzumab.
The study, conducted by the German Breast Group, enrolled women with HER2-positive locally advanced or metastatic breast cancer who had previously received trastuzumab with or without chemotherapy as first-line treatment.
They were randomly assigned to receive trastuzumab at a dose of 6 mg/kg every 3 weeks with oral capecitabine at a dose of 2500 mg/m2 on days 1 to 14 every 21 days or capecitabine treatment alone. The final analysis included 156 patients.
"It is rewarding to see that trastuzumab keeps working in women whose aggressive HER2-positive breast cancer progresses," said Gunter von Minckwitz, MD, PhD, University Women's Hospital and German Breast Group, Frankfurt, Germany.
"The GBG-26 study results confirm that trastuzumab continues to target and shrink the cancer even beyond progression when combined with another chemotherapy [agent]," Dr. von Minckwitz said.
ASCO 2008: ABSTRACT #1025: Capecitabine vs. capecitabine + trastuzumab in patients with HER2-positive metastatic breast cancer progressing during trastuzumab treatment: The TBP phase III study (GBG 26/BIG 3-05)
American Society of Clinical Oncology
Background: There is uncertainty, if trastuzumab treatment should be continued beyond progression (TBP).
Methods: Patients (pts) with HER-2 positive, locally advanced or metastatic breast cancer that progressed during treatment with trastuzumab with or without adjuvant and/or 1st-line metastatic chemotherapy were prospectively randomized to capecitabine (X; 2,500 mg/m2 on days 1-14, q21) or X plus continuation of trastuzumab (XH; 6 mg/kg, q3w). The primary end point was TTP. With registration of lapatinib, the slowly accruing trial was closed prematurely.
Results: Between 01/04 and 05/07 156 pts (X=78; XH=78) were randomized and stratified according to pre-treatment: taxane/trastuzumab as 1st-line therapy (111 pts), taxanes/trastuzumab as adjuvant therapy (3 pts), trastuzumab alone or without taxanes as 1st-line treatment (42 pts). 75 (48.1%) pts were pre-treated with anthracyclines. 119 (76.3%) showed visceral metastasis. Current analysis (median follow-up 11.8 months) revealed a progression-free survival of 5.6 months with 53 events for X and 8.5 months with 48 events for XH (HR=0.71). Brain metastases were observed in 4 (X) and 7 (XH) pts. Overall survival was 19.9 months with 31 events for X and 20.3 months with 26 events in XH (HR=0.79). Crude response rates were 24.6% (X) and 49.1% (XH) and primary progressions were observed in 26.3% (X) and 16% (XH) of patients. Grade III/IV toxicities were (%X/%XH): neutropenia (3.3/6.3), febrile neutropenia (0/0), vomiting (6.0/1.6), diarrhea (20.9/14.8), mucositis (3.0/1.6), hand-foot syndrome (23.9/31.1), nail changes (0/4.9), sensory neuropathy (4.5/3.3), fatigue (6.0/4.9), allergic (3.0/3.3), and cardiac (2.9/4.9). No therapy-related death occurred.
Conclusions: Preliminary results of the TBP study suggest a higher efficacy but similar toxicity for continuing trastuzumab beyond trastuzumab progression when 2nd-line chemotherapy with capecitabine is initiated. Final efficacy analysis will be performed in March 2008.