Herceptin/Navelbine Tx Schedule (also posted in Rec/Met board)

NCdaughter

Hi, I have been reading posts since 2004, but haven't posted much.  My mom was first diagnosed with Stage IIIC (HER2+++ ER/PR+) in '04 and recently found met to the sacrum (HER2++, ER+, PR-).  She has finished radiation and is going to start Herceptin + Navelbine on the 26th.  She got a second opinion and the two oncs disagree on the treatment schedule.  One says Herceptin & Navelbine weekly; the other says Herceptin once every 3 weeks and Navelbine 2 weeks on, then one week off.  Another onc who is a friend assures me these are comparable and I think the research on Herceptin proves that, but all of the studies I can find are with Navelbine weekly.  Is anyone else on this type of schedule or know of any evidence for its efficacy?  I don't know if I am just focusing my stress on this detail, or if it is a really important detail.  Your help is much appreciated. 

HERdaughter

Hi,

 My Mom was StageIIIB on 2006 and 2 years cancer free and October 2007 Mets in Lung so she started weekly Herceptin and Navelbine.So far she had 8 weeks navelbine +Herceptin and Now after Pneumonia her doctor suggested to rest for 6 weeks.I still have the same question that you have so I am looking forward to hear from other members with experience! I also read this article about weekly Navelbine +Herceptin that you may be intrested in:

Navelbine-Herceptin Combo Appears Safe and Effective as First-Line Treatment For HER2-Positive Breast Cancer: Presented at SABCS By Bruce Sylvester SAN ANTONIO, TX -- December 5, 2003 -- Results from a multinational study confirm that Navelbine (vinorelbine) and Herceptin (trastuzumab) in combination is efficacious and safe for first-line treatment for patients with HER2-positive metastatic breast cancer, researchers reported here on December 3rd at the 26th Annual San Antonio Breast Cancer Symposium "This research shows that this combination is not only extremely well tolerated with a lack of significant grade 3 or 4 toxicities, but it is also extremely efficacious," said lead investigator Arlene Chan, MD, medical oncologist, Mount Hospital, Perth, Australia. "We will be looking next at an oral formulation of Navelbine as a way of improving patient compliance." Subject eligibility included HER2-positive metastatic breast cancer with Karnofsky Performance Scale score greater than 70%, normal baseline left ventricular ejection fraction, no prior Herceptin treatment and no prior chemotherapy for metastatic breast cancer. Subjects received weekly intravenous Navelbine (30 mg/m2) and Herceptin (4 mg/kg on Day 1 and then 2 mg/kg) within a 4-week-cycle. The researchers restaged the subjects every 8 weeks. Between October 2000 and June 2002, the investigators enrolled 68 subjects out of 147 patients screened. The median age was 53 years (30-74). The median Karnofsky score was 90% (70%-100%). Rate of prior adjuvant/neoadjuvant chemotherapy use was 66.2% -- anthracyclines 51.1%; anthracyclines + taxanes 28.9%; Cytoxan, methotrexate, 5-fluorouracil 20%. Prior hormonal therapy use was 48.5%. Incidence of visceral metastasis was 75%. The median disease free interval was 19.8 months. Researchers administered a total of 484 cycles with a median of 6 cycles per patient (1 to more than 20). They administered doses of 20 mg/m2 week of Navelbine and 2 mg/kg week of Herceptin. Sixty-five subjects could be evaluated for response to treatment. Forty subjects achieved an objective clinical response (overall response rate [ORR] 61.5%; partial response [PR] 47.7%; complete response [CR] 13.8%). Stable disease was achieved in 23.1% of evaluated patients. The site of metastasis did not affect the results (visceral/non visceral OR 58.8%) or disease free interval (ORR: 56.6%<2yrs; 52.6% >2yrs) nor by previous adjuvant chemotherapy (anthracyclines ORR: 60.9%; anthracyclines + taxanes ORR: 53.8%). "Treatment has been well tolerated," the researchers reported. Incidence of World Health Organization grade 3/4 neutropenia occurred in 46.8% of cycles, with one episode of febrile neutropenia, which was manageable without growth factor support. Reactions to Herceptin infusion were moderate, with grade 3 reactions occurring in 0.2% of cycles; grade 3 asthenia in 2.1% of cycles; grade 3 peripheral neuropathy in 0.8% of cycles; grade 3 constipation in 0.4% of cycles. One patient dropped out of the study for grade 3 cardiotoxicity with symptomatic cardiac dysfunction and decline of left ventricular ejection fraction that resolved with treatment. There were no cases of severe nausea, vomiting or alopecia. [Study title: Navelbine and Herceptin combination as first line therapy for HER 2-overexpressing metastatic breast cancer is a highly active and safe regimen. Final results of multinational trial. Abstract 219]

NCdaughter

Thanks for your reply HERdaughter.  We decided to go with the two weeks on/one week off schedule.  I finally got ahold of my mom's 2nd opinion onc and he agreed this was OK.  It was just nice to hear that we were not giving her substandard Tx.  It seems that with mets there are so many more choices in type and sequence of treatments that it can be very confusing.