Platinum and fluoropyrimidine (F) based peri-operative chemotherapy (PCT) is a standard of care for patients (pts) with operable OGA. Cisplatin (cis) is frequently replaced by carboplatin (CA) for hearing, cardiac or renal impairment, however data for this substitution are lacking. The aim of the study was to examine the efficacy of CA compared to cis for pts treated with PCT at RMH over a ten year period.
Records of pts treated with PCT and surgery (S) with radical intent between 01/2001 and 12/2010 were reviewed. Pt age, sex, ECOG PS, PCT, type of S, pathological stage, dates of disease relapse, death, last follow up were recorded. Overall survival (OS) was estimated using Kaplan Meier method and compared using the log rank test, hazard ratios calculated using a Cox regression model.
261 pts were identified; 188 (cis), 73 (CA) of whom 40 received CA for deafness/tinnitus, 33 for other medical reason (17 cardiac, 15 renal impairment and 1 multiple sclerosis). CA pts were older than cis pts (median 68 vs 62 years). There was no significant difference in gender, PS, site of primary or pre-operative stage between the two groups. In the CA group 60 pts received CA + F (56) or tomudex (4) and 13 pts received CA + F + epirubicin. Median number of cycles was 4 for cis and CA. 30 and 90 day mortality for cis and CA were 1% vs 4% and 3% vs 5% respectively. No significant difference in OS was noted between cis pts and CA pts (3y survival rate 60.5% vs. 58.4%, HR 1.14[95% CI, 0.79-1.74] p = 0.483). There was no significant difference in survival between cis pts or pts who received CA for hearing vs other medical reason (3y survival rate 60.5% vs 62% vs 54.6%, p = 0.774).
|Event||Grade 1-2||Grade 3-4|
|Neutropenia||8 (11%)||9 (12%)|
|Neutropenic sepsis||0||2 (3%)|
|Non-neutropenic sepsis||0||3 (4%)|
|Thrombocytopenia||8 (11%)||2 (3%)|
|Allergic reaction||0||1 (1%)|
|Diarrhoea||7 (10%)||1 (1%)|
|PPE (*)||13 (18%)||7 (10%)|
|Myocardial infarction(â )||0||1 (1%)|
|Angina(â )||1 (1%)||0|
|Peripheral neuropathy||1 (1%)||0|
|Abbr: PPE: palmo-plantar erythrodysesthesia|
|(*) related to capecitabine|
|(â ) in patients with baseline cardiac impairment|
This is the largest study assessing the efficacy of CA in this setting. Operable OGA pts treated with neoadjuvant CA had comparable OS to those treated with cis with an acceptable toxicity profile. For pts unsuitable for cis chemotherapy, CA is an appropriate evidence based treatment option.
Clinical trial identification
All authors have declared no conflicts of interest.