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ESMO 2016 | Selected Oral Presentations: EMZL – clarithromycin dose for treating EMZL is 1g/day
Dr Caterina Cecchetti, from the San Raffaele Scientific Institute in Milan, Italy, and colleagues presented during the ESMO congress in October 2016 in Copenhagen, Denmark, a retrospective study on 55 patients with Extranodal Marginal Zone Lymphoma (EMZL) treated by clarithromycin monotherapy.
The study had three treatment schedules: 500mg clarithromycin twice per day for six months (n=13), three courses of 500mg twice per day for 21 days, every 35 days (n=19), and four courses of 2g per day for 14 days, every 21 days (n=23). The primary outcome was the efficacy and safety of the treatment schedules.
The authors presented data showing that the Overall Response Rate (ORR) of the 1g/day and 2g/day treatment groups were 40% and 46% respectively (P=0.28). Data presented also showed that the Complete Response (CR) rate of the 1g/day and 2g/day treatment groups were 12% and 39%, respectively (P=0.02).
| Response | N(%) | 1 g/day - 32 pts (%) | 2 g/day - 23 pts (%) | P |
| CR | 13 (24) | 4 (12) | 9 (39) | 0.02 |
| PR | 13 (24) | 9 (28) | 4 (17) | |
| ORR | 26 (47) | 13 (40) | 13 (56) | 0.28 |
| SD | 16 (29) | 12 (37) | 4 (17) | |
| PD | 13 (23) | 7 (21) | 6 (26) |
The reported overall Progression Free Survival (PFS) rate, with median follow-up time of 33 months, was found to be 52 ± 7%. The PFS for each treatment group was 60 ± 9% (1g/day) and 42 ± 10% (2g/day).
There was one significant difference in the toxicity profile: the rate of nausea in the 1g/day and 2g/day groups which had a rate of 25% and 52%, respectively (P=0.03). There were no incidence of any grade 4 side effects in either dosage group.
| Clarithro 1 g/day - 32 patients (%) | |||||
| Side effects | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Any Grade |
| Nausea | 5 | 2 | 1 | 0 | 8 (25) |
| Disgeusia | 4 | 1 | 0 | 0 | 5 |
| Dizziness | 2 | 2 | 0 | 0 | 4 |
| Headache | 1 | 0 | 0 | 0 | 1 |
| Arthralgia | 0 | 1 | 0 | 0 | 1 |
| Rash | 0 | 1 | 0 | 0 | 1 |
| Clarithro 2 g/day - 23 patients (%) | |||||
| Side effects | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Any Grade |
| Nausea | 7 | 3 | 2 | 0 | 12 (52) |
| Disgeusia | 2 | 0 | 0 | 0 | 2 |
| Dizziness | 4 | 0 | 0 | 0 | 4 |
| Headache | 2 | 0 | 0 | 0 | 2 |
| Arthralgia | 0 | 1 | 0 | 0 | 1 |
| Rash | 1 | 0 | 0 | 0 | 1 |
The main conclusion from this presentation was that in future the recommended dose should be 1g/day to balance efficacy and tolerability. At the end of the presentation a new trial of clarithromycin was discussed. The CLEO trial is a phase II trial using 1g/day clarithromycin in combination with lenalidomide in patients with R/R EMZL.
Following Dr Caterina Cecchetti’s presentation, a discussion session was held, led by Dr Armando López-Guillermo from Instituto Oncológico Baselga, Barcelona, Spain. Dr López-Guillermo commented on the anti-tumor mechanisms of action of clarithromycin which included increasing the activity of macrophages and reducing neutrophil production of Vascular Endothelial Growth Factor (VEGF).
