The purpose of this study was to evaluate the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS, DoceAqualip)-based chemotherapy in breast cancer. Methods: Medical charts of patients with breast cancer, who were treated and followed up with NDLS (75-100 mg/m 2 ; 3-week cycle)-based chemotherapy from August 2014 to September 2018, were analyzed in this multicenter, retrospective study. The study endpoints were overall response rate (ORR: complete response [CR]+partial response [PR]) and disease control rate (DCR: CR+PR+stable disease [SD]) in neoadjuvant and metastatic settings. Overall survival (OS) and safety were evaluated for all settings. Results: Of 91 patients (neoadjuvant: 12, adjuvant: 61, metastatic: 18), efficacy evaluation in 29 patients (neoadjuvant: 12/12, metastatic: 17/18) demonstrated an ORR and DCR of 100%, respectively, in the neoadjuvant setting, and an ORR of 64.7% and DCR of 70.6%, respectively, in the metastatic setting. At a median follow-up of 21.6 months (range: 2.1 to 49.9 months), median OS was not reached in neoadjuvant and adjuvant settings, and it was 30.4 months in metastatic settings. At least one adverse event (AE) was reported in 59.3% of patients. Anemia, thrombocytopenia, lymphopenia, and neutropenia were the most common hematological AEs reported while hyperglycemia and alteration in liver function tests were the most common non-hematological AEs. NDLS-based treatment was well tolerated without any new safety concerns. Conclusion: Nanosomal docetaxel lipid suspension-based chemotherapy was efficacious and well tolerated in the treatment of breast cancer. Further, NDLS is being evaluated prospectively in patients with triple-negative breast cancer (ClinicalTrials.gov: NCT03671044).
The management of breast cancer with advanced disease or metastasis is a common problem in India and other countries. A panel of 13 oncology experts deliberated on the sidelines of the 35th Indian Cooperative Oncology Network Conference held in Mumbai to formulate an expert opinion recommendation on the novel drug delivery system (NDDS) formulations in the treatment of metastatic breast cancer (MBC). The survey comprised of 39 questions related to limitations of conventional formulations and therapeutic positioning of NDDS formulations of docetaxel, paclitaxel and doxorubicin in the management of MBC. The experts used data from published literature and their practical experience to provide expert opinion and recommendations for use by the community oncologists. The experts opined that the newer NDDS formulations should provide a significant efficacy advantage in terms of overall survival and progression-free survival, or demonstrate better tolerability when compared with conventional formulations. The newer NDDS formulations of taxanes should be considered in special circumstances such as diabetes, in patients who have had hypersensitivity reactions and in cases where steroids need to be avoided. The novel formulations of doxorubicin should be used in the elderly and in patients with borderline cardiac function.
Penile squamous cell carcinoma (pSCC) is a relatively rare disease in Western world but is a significant health problem in developing countries like India. We report here a case of successful multimodality management of recurrent pSCC with pelvic lymphadenopathy in a 56-year-old male patient with poorly controlled diabetes. The patient presented with ulceroproliferative growth over the residual penile stump clinically involving root of penis and with right pelvic lymphadenopathy. The patient had a history of partial penectomy done elsewhere 20 months ago. In view of the comorbidities, locally recurrent disease and presence of right Iliac lymphadenopathy, the patient was treated with nanosomal docetaxel lipid suspension (NDLS), cisplatin and 5-fluorouracil (TPF regimen) in the neoadjuvant setting followed by staged surgical resection. This is the first case report showing successful treatment of recurrent pSCC with NDLS-based TPF regimen in the neoadjuvant setting followed by staged surgery in a patient with poorly controlled diabetes.
Squamous cell carcinoma (SCC) of the pancreas is a rare tumor with only a few case reports available. It is an aggressive form of pancreatic cancer with a poor prognosis. The diagnosis and optimal management of SCC of the pancreas is poorly defined due to the lack of standard treatment or guidelines and owing to the rarity of this malignancy. Patients suffering from SCC of the pancreas do not respond well to chemotherapy or radiotherapy and isolated reports are available on the use of gemcitabine and newer taxane formulations. Surgical resection of the tumor is the most effective modality; however, due to a delay in diagnosis, the majority of pancreatic SCCs remain unresectable. Herein, a case of SCC of the pancreatic tail is reported in a 60-year-old patient who was managed with a combination of albumin-free nanosomal paclitaxel lipid suspension (NPLS) and gemcitabine in a neoadjuvant setting. To the best of our knowledge, this is the first such case report of a locally advanced SCC of the pancreatic tail showing an overall survival of 1 year following treatment with an NPLS based regimen. The treatment was well tolerated with no serious safety concerns.
The standard of care for locally advanced cervical cancer has been the combination of a taxane with platinum based therapy. Conventional docetaxel is known to cause hypersensitivity reactions, fluid retention and other toxicities due to polysorbate-80 and ethanol. Corticosteroid premedication prior to docetaxel administration is required to prevent these toxicities, however, toxicities are still observed, sometimes fatal, despite premedication. DoceAqualip, a nanosomal docetaxel lipid suspension, developed with lipids generally regarded as safe (GRAS) by the US Food and Drug Administration, is devoid of polysorbate-80 and ethanol. DoceAqualip has been demonstrated to be effective and well-tolerated in various cancer types. The authors' report a case of a patient with Stage IIIB cervical cancer who was treated with carboplatin and DoceAqualip (concurrent ChemoRT) and achieved complete response without any serious adverse events.
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