Overall Prof V M Patil has treated over 1.0 lakh cancer patients so far. He has administered and supervised immunotherapy injections in over 1000 patients, targeted therapies in over 10,000 patients, metronomic chemotherapy in over 15,000 patients and chemotherapy in over 50,000 patients. He has developed many novel regimens and criteria for treatment. Examples include Patils criteria for Borderline resectability, Safeguards for administering TPF (DCF) regime in Head and neck cancer, development of metronomic regimens, development of low-cost immunotherapy regimen, development of chemo-targeted regimen for driver mutated lung cancers, adjuvant therapy for penile cancers, low dose bevacizumab -CCNU regimen for Gliomas, safeguards for PCV regimen for low -intermediate grade glioma, video follow up in cancer etc. Several of these had a significant impact on treatment effectiveness and costs for patients.
Conceptualised by Professor Kumar Prabhash and I. immunotherapy regimens for treatment of advanced head and neck cancer are accessible to only 1%-3% patients because of their high cost. Hence developed a low dose dose immunotherapy regimen. This low dose regimen improves outcomes and quality of life. In addition, this brought the treatment cost down from 60-70 lakhs per year to below 5.0 lakhs per year. We performed the first-ever randomized study to demonstrate that addition of low dose nivolumab to OMCT improved survival and is an alternative standard of care for those who cannot access full-dose.
Key takeaway: Immunotherapy is accesible to only 1-3% of patients due to high cost. We conceptualised and proved that a novel low-dose regimen is also effective while bringing down costs by greater than 90%.
This work was performed by me, in collaboration with Professor Kumar Prabhash and Professor Shripad Banavali. We identified in 2010, that the head and neck cancer palliative systemic therapy regimen of choice, the EXTREME regimen (per month cost used to be 3.5-4.0 lakhs) was unaffordable to greater than 90% of our patients. In addition, this regimen was intravenous hence requiring frequent hospital visits. It led to severe side effects in 82% of patients. Hence the majority of head and neck cancer patients were unable to take this regimen. Hence, we started using an oral metronomic combination therapy of methotrexate and celecoxib. This regimen was oral, had good results and used to cost about 1000 rupees per month. The initial cohort studies of 18 and 64 patients were published in the Indian journal of cancer and clinical oncology journal. Subsequently, using this data, we ran a randomized phase 2 study of 110 patients (2011-2013) in which this metronomic regimen was compared against the intravenous chemotherapy regimen. This phase 2 randomised study showed that the oral double metronomic regimen of methotrexate and celecoxib was better than the IV standard cisplatin regimen both in terms of better outcomes and fewer side effects. With these encouraging results, we performed a phase 3 study (2015-2020) comparing the low-cost metronomic regimen against the intravenous cisplatin regimen in 400 plus patients. This study proved beyond doubt that the oral metronomic regimen is better tolerated, has better outcomes and also leads to improvement in quality of life. This study was published in Lancet Global health and now this oral, low-cost regimen is considered one of the standard regimens and has entered practice guidelines.
Key takeaway: Existing palliative treatment of choice was unaffordable to 90% of patients with advanced head and neck cancer and caused distressing side effects in 82% and required hospital access for IV administration. We developed a regimen that’s very cheap, given orally and was proven to be more effective and with fewer side effects than the previous treatment of choice.
This work was performed by me, in collaboration with Professor Kumar Prabhash, Professor Manoj Mahimkar, Dr Atanu Bhattacharjee, Professor Vikram Gota and Professor Shripad Banavali. We identified that double metronomic chemotherapy, docetaxel, cabazitaxel, though useful, was not working in platinum-refractory head and neck cancers ie, patients who fail after receiving cisplatin. So, we decided to biologically model it. However, there were no effective statistical models available for biologically modelling of this regimen as most chemotherapies are doses with the concept of maximum tolerable dose. So traditional phase 1 studies looked at adverse events as a criterion for the selection of dose. However, in metronomic dosing, the doses used are low and hence these traditional phase 1 models would fail. Hence, we made an innovative model where we would track the decline in circulating endothelial cells from baseline at day 8 and decrease in size of the tumour on radiological scans. Using this model, we made the first-ever phase ½ study of metronomic dosing. This biologically effective dose led to incredibly high response rates, improvement in quality of life and outcomes similar to that of immunotherapy drugs. These results were published in the Journal of clinical oncology (impact factor-44.5), one of the highest impact factor journals in oncology. The difference was immunotherapy drugs(Nivolumab or Pembrolizumab) for 1-month treatment cost 3-4 lakhs while this treatment cost 2000 rupees only.
Key takeaway: Conceptualized and developed an alternative regimen to immunotherapy in a specific subset of patients (platinum-refractory head and neck cancer) which proved similarly effective and tolerated as immunotherapy at under 1% of its cost.
This work was performed in collaboration with Professor Kumar Prabhash, Professor Vanita Noronha, and Professor Shripad Banavali. It was an age-old question that which schedule of cisplatin (weekly or 3 weekly) along with radiation is the best. The answer was provided in this study which was a phase 3, randomised first ever study answering this question. The results were published in the Journal of clinical oncology , one of the highest impact factor journals in oncology.
Key takeaway: Provided robust, treatment-affecting data on the optimal regimen for cisplatin usage concomitant to radiation in head and neck cancer.
This work was performed in collaboration with Professor Kumar Prabhash, Professor Vanita Noronha and Professor Manoj Mahimkar. Nimotuzumab is an EGFR targeting antibody and we studied in a 500 Plus patient randomised phase 3 study whether the use of Nimotuzumab along with cisplatin would improve outcomes. This indeed improved outcomes and the results were published in the Cancer Journal of American Cancer Society and the Oncologist journal.
Key takeaway: Provided robust data to prove efficacy of novel drug Nimotuzumab when added to cisplatin in head and neck cancers.
This work was performed in collaboration with Professor Kumar Prabhash. There was no standard of care treatment to be given with radiation in cisplatin ineligible patients. Docetaxel as radiosensitizer was conceptualized and a large phase 3 study was done. This study proved that Docetaxel improved outcomes over radiation alone. This indeed improved outcomes and the results were presented at ASCO 2022 meeting.
Key takeaway: Provided robust data to prove efficacy of drug docetaxel when added to radiation in cisplatin ineligible head and neck cancers.
This work was performed in collaboration with Professor Kumar Prabhash and Professor Devendra Chaukar. In surgery for oral cancer, often the mandible has to be cut, Hence, we designed a strategy whereby giving neoadjuvant chemotherapy will lead to a shrinkage of the tumor and hence surgery would be done with preservation of the mandible. Preservation of the mandible leads to better cosmesis, better Qol and better oral functions. Hence this was an important study. We did a randomised study and the long-term outcomes proved that the mandible can be preserved without impact on cancer-related outcomes. That is preservation of the mandible after NACT does not lead to an early recurrence of cancer. This randomised study was published in the Journal of clinical oncology , one of the highest impact factor journals in oncology.
Key takeaway: Conceptualised giving a kind of chemotherapy (neoadjuvant chemotherapy) which led to shrinkage of jaw tumours to the point where they could be surgically removed without having to remove the jaw and thus preserving it for the patient.
In India 80-85% of patients present in a locally advanced stage. In many instances, the cancer is so advanced that surgery is not possible. If treated with radiation then most patients die within 1 year. Hence, we developed a strategy of treating these patients with neoadjuvant chemotherapy. Once tumor shrink post neoadjuvant therapy we would operate on them. This strategy led to a prolongation of life.
Key takeaway: Head and neck cancers are often advanced when they are first seen by doctors and hence surgery is not possible on them. We showed that by giving neoadjuvant chemotherapy, these advanced tumours could be shrunk down enough for them to be operated upon hence prolonging patients’ lifespan.
Dr Vijay Patil has experience of treating multiple systemic therapies including targeted therapies, sorafenib, lenvatinib, cabozantinib, vandetanib, RET inhibitors, B-RAF inhibitors and immunotherapy.
Dr Vijay Patil has experience of treating with multiple systemic therapies including targeted therapies, axitinib, TDM-1, Trastuzumab, Trastuzumab-Pertuzumab, sorafenib, lenvatinib, cabozantinib, vandetanib, RET inhibitors, B-RAF inhibitors and immunotherapy.
Dr Vijay Patil has experience of treating with multiple systemic therapies including targeted therapies and immunotherapies. He developed the neoadjuvant regimen of Cisplatin & etoposide in sinonasal malignancies.
Dr Vijay Patil has experience of treating with multiple systemic therapies including targeted therapies and immunotherapies.
This work was done in collaboration with Professor Kumar Prabhash and Professor Vanita Noronha. EGFR mutated tumours are seen in India in 20-30% of patients. We did a phase 3 randomised study comparing oral once-daily gefitinib with pemetrexed carboplatin intravenous therapy. The oral drug was found to improve disease control with fewer side effects and thus is considered standard therapy. This work was published in 2017. We further refined this therapy and saw whether the addition of intravenous chemotherapy to oral gefitinib improves outcome over gefitinib alone. It did indeed improve outcomes. Today this regimen has entered textbooks and guidelines as standard therapy for this cancer. Both these papers were published in ESMO OPEN and Journal of clinical oncology respectively.
Key takeaway: Conceptualised and proved how oral tablet of geftinib was superior to prevalent IV first-choice treatment. Then went a step ahead to provide robust data on how the addition of IV chemotherapy to the oral tablet was even better; this is now accepted as a standard treatment guideline and has been published as such by international bodies.
This work was done in collaboration with Professor Kumar Prabhash and Professor Vanita Noronha. Prolonged infusion of low-dose gemcitabine (PLDG) in combination with platinum has shown promising activity in terms of improved response rate and progression-free survival (PFS); especially in squamous non-small cell lung cancer (NSCLC). Hence, we conducted a phase 3 randomized non-inferiority study with the primary objective of comparing the overall survival (OS) between PLDG and standard dose of gemcitabine with platinum. This study suggests that PLDG is an alternative to the standard gemcitabine schedule in squamous NSCLC, and either of these can be selected subject to patient convenience. This regimen could bring down treatment cost by 1/4th. This got accepted in EclinicalMedicine Journal. This is a Lancet group of journals.
Key takeaway: Conceptualized and then proved an alternative treatment being equally effective to the prevailing standard treatment in a type of lung cancer while being 25% cheaper.
We planned to compare pemetrexed maintenance with erlotinib maintenance in non-squamous non-Epidermal Growth Factor Receptor (EGFR) mutated non-small cell lung cancer (NSCLC). The null hypothesis for this study was that there would be no difference in quality of life (QOL) between pemetrexed and erlotinib maintenance. The idea was to replace intravenous therapy with an oral drug. This would decrease hospital visits and the cost of treatment. The study was an open-label, single-centre, parallel, phase 3 randomized study with 1:1 randomization between maintenance pemetrexed arm and erlotinib arm. Both treatments had similar QOL suggesting that oral therapy could replace intravenous therapy.
Key takeaway: Proved that an oral drug gave a similar quality of life as the currently used IV drug in maintenance of a lung cancer thus providing an alternative that would allow decreased hospital visits and cost associated with having to give a drug by the IV route.
I have helped in establishing the safety and efficacy of immunotherapy in lung cancer, esophageal cancer, head and neck and CNS tumors in India. One of the first and largest series was published in this setting by Dr Patil and his colleagues.
ALK, ROS, RET, MET, BRAF, NTRK, FGFR3 and other mutations are treated with multiple targeted therapies like Crizotinib, ceritinib, Lorlatinib, Alectinib, Brigatinib, selpercatinib, pralsetinib, capamatinib, tepotinib , larotrectinib or entrectinib, Pemigatinib, Erdafitinib, Vemurafenib (Zelboraf), dabrafenib (Tafinlar), and encorafenib (Braftovi) etc. Dr Patil has one of the largest experience which is published in most of them and is well worsed with there use.
This work was done by me in collaboration with Professor Jalali. Gliomas are the commonest primary brain malignancies seen in adults. Many of these patients have significant physical or cognitive dysfunction and need significant psychosocial support from the caregiving team. Getting these patients to hospitals is difficult and hence we performed this study to study whether video follow-ups can replace clinical follow-up. This was a randomised study and it showed that video follow up can substitute clinical follow up. This study was published in 2018 and was a great boon during the COVID time.
Relapsed high-grade glioma has dismal outcomes. Mebendazole has shown promising activity against glioma in in-vitro and in-vivo studies. Hence, we undertook a phase 1 study to repurpose mebendazole in the treatment of glioblastoma. We recommended phase 2 dose of mebendazole is 1600 mg TDS with temozolomide and temozolomide-radiation combination while the dose of 800 mg TDS needs to be used with single-agent CCNU.
Key takeaway: Conceptualised and proved effectiveness of a repurposed, easily available anti-parasitic medicine in treating a high grade type of brain cancer ie glioma.
Original bevacizumab is costly. Hence, we worked on low-dose bevacizumab and on generic bevacizumab. Both these publications have helped in establishing the role of generic and low-dose bevacizumab
Management of brain metastasis is a complex multidisciplinary venture. Hence, we started a multidisciplinary brain metastasis clinic for the opinion on difficult brain metastasis cases. This was the review of the impact of this clinic on treatment decisions. The brain metastasis clinic (BMC) was started in April 2018 and meets once a week. Data of patients discussed between 27th April 2018 and 28th June 2019 were included for this analysis.The treatment plan was changed in 46 patients (46.5%). The intent of treatment was changed from palliative to curative in 5%. Change in the treatment plan with respect to surgery in 9.1%, radiation in 37.4%, chemotherapy in15.2%, targeted therapy in 22.9% and intrathecal in 6.1% patients, respectively. The compliance with the BMC decision in patients in whom it was changed was 84.8% (39, n = 46).
Key takeaway: Showed how a multidisciplinary structure to discuss complex brain metastasis cases can impact and improve care.
We studied and established the role of Paclitaxel-Platinum as adjuvant and palliative therapy in Penile cancers.
We studied and established the safety and efficacy of multiple targeted therapies and immunotherapy in renal cell carcinoma
We studied and established the safety and efficacy of multiple chemotherapy and targeted therapies Prostate Carcinoma
Dr Patil has established and studied multiple regimens (Chemotherapy, targeted therapy and Immunotherapy) in adjuvant, neoadjuvant, concurrent and Palliative settings in GI tumors.
Have established internationally recognised protocols for treatment in Breast and Gynecological cancers while at Malabar Cancer center
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