Abstract 1049P
Background
Immunotherapy has improved outcomes in many advanced solid tumors. In resource constrained settings, less than 2% patients are able to take routine dose immunotherapy. A recent phase II study showed efficacy of low dose immunotherapy in this setting. We used low dose immunotherapy in patients on compassionate basis who wanted immunotherapy and was without any standard treatment option.
Methods
We retrospectively collected data from medical oncology department for patients who had received initially standard lines of therapy followed by low dose immunotherapy (Nivolumab 40 mg) on a compassionate basis. The demographic details, histology, prior treatment, clinical and radiological response, date of disease progression, date of death and toxicity data were collected. We included patients who was started on treatment on 14th February,2020 or earlier.
Results
There were 71 patients in the database who received low dose immunotherapy. 54 patients received it before the above mentioned date in methods. 4 patients were not evaluable. Median age was 50.4 years (range 35-74 years), Male: female ratio was 6:1. The most common comorbidities were hypertension and diabetes seen in 12 (22.2%) and 6 (11.1%) patients respectively. The majority of the patients (70.4%) were of head and neck cancer. The median follow up was 4.5 months (range 0.5-11.7). Clinical benefit was observed in 18 (33.3%) patients. Partial response and stable disease were present in 9 (16.7%) and 5 (9.3%) patients respectively. Median survival was not reached for these patients. Six months progression free survival and overall survival were 100% vs 8.7% (HR-0.05 95% CI 0.01-0.36; p=0.003) and 100% vs 29.7% (HR-0.03;95% CI 0.00-0.95; p=0.047) respectively for responders and non-responders. The treatment was well tolerated. Table: 1049P
| Age -median (Range) (years) | 50.4 (35-74) |
| Sex- n (%) | |
| Male | 46 (85) |
| Female | 8 (15) |
| ECOG-PS -n (%) | |
| <2 | 48 (89) |
| ≥ 2 | 6 (11) |
| Sites of disease- n(%) | |
| Urinary bladder | 3 (5.6) |
| Renal | 4 (7.4) |
| Lung | 9 (16.7) |
| Head and Neck | 38 (70.4) |
| Prior lines of therapy-n (%) | |
| 0 | 2 (3.7) |
| 1 | 29 (53.7) |
| ≥ 2 | 23 (42.6) |
| Cycles of nivolumab received -n | |
| <2 | 13 |
| 2-4 | 25 |
| 5-8 | 10 |
| 9-12 | 3 |
| >12 | 3 |
Conclusions
In resource constrained settings, low dose immunotherapy seems to be an effective treatment option. Further phase II/III study is warranted to validate this approach.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Tata Memorial Centre.
Funding
Has not received any funding.
Disclosure
V. Noronha: Research grant/Funding (institution), Outside the submitted work: Dr Reddys Laboratories; Research grant/Funding (institution), Outside the submitted work: Amgen; Research grant/Funding (institution), Outside the submitted work: Sanofi Aventis. K. Prabhash: Research grant/Funding (institution), Outside the submitted work: Biocon Ltd; Research grant/Funding (institution), Outside the submitted work: Dr Reddy's Laboratories; Research grant/Funding (institution), Outside the submitted work: Fresenius Kabi India Pvt Ltd; Research grant/Funding (institution), Outside the submitted work: Alkem Laboratories; Research grant/Funding (institution), Outside the submitted work: Natco Pharma Ltd; Research grant/Funding (institution), Outside the submitted work: BDR Pharmaceuticals Into Pvt Ltd; Research grant/Funding (institution), Outside the submitted work: Roche holding AG. All other authors have declared no conflicts of interest.