Trastuzumab in the treatment of elderly patients with early breast cancer: Results from an observational study in Germany.
BACKGROUND
In elderly patients with HER2-positive breast cancer, few data on efficacy and toxicity of adjuvant trastuzumab treatment exists since older patients were in general excluded from large randomized studies. This prospective observational study aimed to confirm the beneficial findings from pivotal trials in age cohorts ≥65 years.


METHODS
There were no restrictions for recruitment with respect to age or concomitant/sequential adjuvant medication. Long-term relapse/survival status of the patients was assessed once a year.


RESULTS
Among the 3940 evaluable patients enrolled between 2006 and 2012 at 339 institutions, 507 were aged between 65 and 69 years, with another 507 patients ≥70 years. Elderly patients suffered from significantly more advanced primary tumors. Preceding or concomitant chemotherapy showed decreasing aggressiveness with patient's age. Trastuzumab treatment was stopped prematurely in only 11% of the elderly, but more often than in younger patients (p=0.0008). With 453 events hitherto reported, elderly patients did not exhibit an inferior relapse-free survival when adjusted for other relevant prognostic factors (hazard ratio: 1.01 per year; p=0.24). Three-year overall survival was significantly lower in the population older than 64 years than in younger patients (94.2% vs. 96.8%, p=0.0011).


CONCLUSIONS
To our knowledge, our population of elderly patients treated with adjuvant trastuzumab is the largest analyzed so far. The beneficial long-term results were comparable to those in the younger cohorts. Although the risk of cardiotoxicity increased significantly with age, it also remained manageable in older patients. Thus, chronological age alone should not preclude HER2 antibody treatment.
Department of Obstetrics and Gynaecology and Breast Cancer Center, Klinikum Lüneburg, Lüneburg, Germany. Electronic address: peter.dall@klinikum-lueneburg.de.
Peter
P
Dall
Oncology Practice, Osnabrück, Germany.
Gertrud
G
Lenzen
Onkozentrum Dresden/Freiberg, Dresden, Germany.
Thomas
T
Göhler
Oncology Practice, Münster, Germany.
Christian
C
Lerchenmüller
Department of Obstetrics and Gynaecology and Breast Cancer Center, Klinikum Kassel, Kassel, Germany.
Gabriele
G
Feisel-Schwickardi
Breast Center, Klinikum Nürnberg, Nürnberg, Germany.
Thorsten
T
Koch
Oncology Practice, Moers, Germany.
Jochen
J
Eggert
Oncology Practice, Günzburg, Germany.
Volker
V
Heilmann
Gynecology Practice, Leipzig, Germany.
Christof
C
Schindler
Oncology Practice, Fürth, Germany.
Jochen
J
Wilke
Onkologie Bethanien, Frankfurt, Germany.
Hans
H
Tesch
Oncology Practice, Duisburg, Germany.
Johannes
J
Selbach
Roche Pharma AG, Grenzach-Wyhlen, Germany.
Tim
T
Wohlfarth
WiSP Research Institute, Langenfeld, Germany.
Heidi
H
Eustermann
WiSP Research Institute, Langenfeld, Germany.
Axel
A
Hinke
D000367:Age Factors; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D000068878:Trastuzumab / Q000009:adverse effects / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
Early breast cancer; Elderly patients; Her2 overexpression; Non-interventional study; Trastuzumab