Triple combination of palliative oral metronomic chemotherapy in recurrent and metastatic epithelial ovarian cancer: A retrospective study.

Background: Ovarian cancer is a leading cause of death from gynecological cancer in the world and in India. This study aims to evaluate the efficacy and toxicity profile of oral metronomic chemotherapy (MCT) in the form of etoposide, cyclophosphamide, and tamoxifen in recurrent and metastatic ovarian cancer. Methods: This was a retrospective observational study that included those post-treatment patients who had the recurrent or metastatic disease after completion of treatment in 2018 at Regional Cancer Centre, Bikaner, Rajasthan. Forty patients who were unfit for further intensive intravenous chemotherapy were included. The oral MCT constituted etoposide, cyclophosphamide, and tamoxifen. Descriptive statistics and Kaplan-Meier analyses were performed. Progression-free survival (PFS) and overall survival (OS) were assessed. Results: Forty women with a median age of 62 (range: 35-80) years were enrolled in the study to receive oral MCT. The Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) was 0-1 in 28 patients and 2-3 in 12 patients. The best clinical response rate post-oral MCT was seen in the first 4 months. Objective response was observed in 24 (60%) of patients in the form of stable disease (19, 47.5%) and partial response (5, 12.5%). Disease progression was observed in 10 (25%) of patients. The median follow-up was 6.4 months (4.5-9.2 months). The median estimated OS was 6.5 months. The median estimated PFS was 3.7 months. Nineteen (47.5%) patients had grade-I/II mucositis. Grade-III/IV mucositis were observed in 9 (22.5%) patients. Thirty-seven (92.5%) patients died at the end of the study at 1 year. Dose reduction was required in 15 (37.5%) patients. Conclusion: Oral MCT was found to be an effective and well-tolerated regime with good symptomatic control and low-moderate toxicity profile in patients with relapsed and metastatic ovarian cancer. However, 22% of patients showed grade-III/IV thrombocytopenia.

Role of maintenance paclitaxel in epithelial ovarian cancer: An affordable option for poor resources countries (a Regional Cancer Institute study).

Purpose: The purpose of the study is to assess the benefits of maintenance chemotherapy (CT) in epithelial ovarian cancer with CT and surgery. The primary and secondary endpoints of the study were progression-free survival (PFS) and overall survival (OS), respectively. Patients and Methods: Three hundred patients with ovarian cancer (registered between January 2012 and December 2013) received 6 cycles of 3 weekly CT (injection paclitaxel 175 mg/m2 + injection carboplatin 6 AUC) and surgery. After 4 weeks of completion of the above treatment, patients were assessed for response with radiological imaging and serum CA125. Then, these patients were randomly allotted in two arms; 150 patients in Arm A received 6 cycles of single agent, 3 weekly injection paclitaxel 175 mg/m2 as maintenance therapy while 150 patients in Arm B, were on observation. The follow-up was done at 1 month, then 3 monthly in the 1st year and 6 monthly in the 2nd year to evaluate PFS and annually up to 5 years for OS. Results: The PFS at 1 and 2 years was 91% and 80% in study arm and 65% and 50% in control arm; the differences were statistically significant (P = 0.010). The 5-year overall survival was 43% versus 38% in study and control arms, respectively (P = 0.410) and 5-year PFS was 28% versus 18% (P = 0.039) in maintenance and observation arm, respectively. Except for peripheral neuropathy, there was no statistically significant difference in toxicities between the two arms. Conclusion: The study suggests that 6 cycles of single-agent paclitaxel maintenance therapy significantly prolongs the duration of PFS and better trends toward OS, though a large study is needed to come to a conclusion.

Retinoblastoma: A review of clinical profile at a regional cancer center in Northwest India.

Background: Retinoblastoma is the most common primary intraocular malignancy of childhood. The present study was undertaken to overcome the scarcity of data regarding the epidemiology, demographic and clinical profile, and nature of the first health-care professional consulted. Materials and Methods: A retrospective analysis of medical records was performed for all cases of retinoblastoma who presented to the department of ophthalmology and oncology between 2010 and 2017. A total of 54 cases were reviewed. Results: Unilateral disease was seen in 85.2% while 14.8% presented with bilateral disease with a median age of 3 years and 2 years, respectively, at diagnosis. The male: female ratio was 2:1. The most common presenting symptom was leukocoria which was noticed in 42 patients (77.7%), followed by red eye (33.3%) and proptosis (20.3%). The most common stage of presentation was Stage I (44.4%), followed by Stage IV (20.4%), Stage III (9.3%), and Stage II (5.6%). The median time to diagnosis was 8.7 months (range, 0.5-98.7 months), and the median time to treatment was 37.4 days (range, 0-645 days). Majority of the patients were referred by local ophthalmologists (48%), followed by general practitioners (20%), nurses (19%), and quacks (13%). Enucleation was the most preferred treatment modality (48.1%), followed by chemotherapy (33.3%), radiotherapy (13%), photocoagulation (3.7%), and exenteration (1.9%). The overall remission rate was 79.6%, while 12.3% had relapse and 7.4% died. Conclusion: The study showed a dire need for timely detection and treatment of retinoblastoma which is possible with improved awareness and better accessibility to health-care facilities. It also revealed a decrease in histopathological risk factors with chemoreduction.

Rituximab biosimilar RTXM83 versus reference rituximab in combination with CHOP as first-line treatment for diffuse large B-cell lymphoma: a randomized, double-blind study.

This multicenter, double-blind, randomized study compared the efficacy, pharmacokinetics (PKs)/pharmacodynamics (PDs), safety and immunogenicity profile of RTXM83 vs. reference rituximab (R-rituximab), both with CHOP, as first-line treatment of diffuse large B-cell lymphoma (DLBCL). A total of 272 patients <65 years of age, with good prognosis (136 per arm) were randomized (1:1) to receive six cycles of either RTXM83 or R-rituximab. The primary efficacy endpoint was achieved (overall response rate of 83.6% for RTXM83 and 82.9% for R-rituximab) with a difference 0.7% between arms (95%CI: [-8.77% to 10.17%]) fulfilling the predefined non-inferiority margin (-13%). Similar number of patients reported at least one adverse event (AE) (131 per arm) or one serious AE (47 with RTXM83 and 45 with R-rituximab). Anti-drug antibody development was comparable between the arms. PK/PD secondary endpoint results support similarity between the compounds. RTXM83 exhibits non-inferior efficacy and similar safety/immunogenicity to R-rituximab, being an accessible alternative for the treatment of patients with previously untreated DLBCL.

Analysis of outcomes and prognostic factors of acute lymphoblastic leukemia patients treated by MCP841 protocol: A regional cancer center experience.

BACKGROUND: A dramatic improvement in the survival of acute lymphoblastic leukemia (ALL) patients in the last three decades has been observed. MCP 841 protocol is an old but effective tool with tolerable toxicities. The objective of this study was to estimate the relapse-free survival of ALL patients treated uniformly with MCP 841 protocol on the basis of various prognostic factors. MATERIALS AND METHODS: The study design was retrospective and it was conducted in a regional cancer center of Northwest India. Three hundred and ten ALL patients who underwent treatment with MCP 841 protocol and regular follow-up for up to 5 years were selected for this study. Relapse-free survival was calculated by Kaplan-Meier analysis and Cox regression analysis was used to calculate the hazards ratio (HR) using Statistical Package for the Social Sciences (SPSS) software for windows version 20.0. RESULTS: Fifty-four percent patients were <15 years of age and 69% were males. 53.2% patients were in remission at the end of 5 years of starting the treatment. Relapse-free survival at 5 years by Kaplan-Meir analysis for B-cell ALL was 62% [HR 0.67 {95% confidence interval (CI) 0.47-0.95}] with patients with unknown lineage taken as reference] while for T cell it was 28% [HR 1.41 (95% CI 1.19-1.63), P 0.001]. Patients with total leukocyte count (TLC) <1 lakh/cmm at presentation, relapse-free survival was 68% and those with TLC >1 lakh/cmm had 41% survival [HR 2.14 (1.76-2.48) with, P < 0.001]. CONCLUSION: MCP 841 protocol is a useful tool for the treatment of ALL in children when more aggressive protocols can not be used.

Metronomic therapy with oral 6-mercaptopurine in elderly acute myeloid leukemia: A prospective pilot study.

INTRODUCTION: Acute myeloid leukemia (AML) in elderly patients differs biologically from that in younger patients and is known to have unfavorable chromosomal rearrangements, higher resistance, and lower tolerance to chemotherapy. In such circumstances, instead of giving full-blown chemotherapy, palliative metronomic chemotherapy (MCT) could be a treatment option. PATIENTS AND METHODS: We performed a prospective pilot study of old AML patients (age >60 years) not amenable to curative treatment. Thirty-two patients were enrolled into the study and were treated with daily oral 6-mercaptopurine 75 mg/m(2). The following inclusion criteria were used: age >60 years, nonpromyelocytic AML, the absence of uncontrolled comorbidities, and patient not amenable to curative treatment. Overall survival (OS) was calculated using Kaplan-Meier method and Cox regression analysis were used to calculate the hazards ratio of significant factors. RESULTS: The median age of the patients was 69 years (range: 61-86 years) with male: female ratio of 2.5:1. About 59.4% of patients had Eastern Cooperative Oncology Group performance status of 2 while rest had the status of 3. The median OS was 6 months (95% confidence interval [CI]: 4.4-7.6). Males had median OS of 7 months (95% CI: 5.4-8.6) versus females with OS of 3 months (95% CI: 1.5-4.4; P = 0.008). There was no survival difference on the basis of baseline hemoglobin or French-American-British class. There were no Grade 4 toxicities and no episode of febrile neutropenia. CONCLUSIONS: MCT with oral 6-mercaptopurine is an attractive treatment option in elderly AML patients who are not amenable to curative therapy with minimal toxicities.

Management of uveal tract melanoma: A comprehensive review.

Uveal tract melanoma is the most common primary intraocular malignancy in adults, accounting for about 5-10% of all the melanomas. Since there are no lymphatic vessels in the eye, uveal melanoma can only spread hematogenously leading to liver metastasis. A wide variety of treatment modalities are available for its management, leading to dilemma in selecting the appropriate therapy. This article reviews the diagnostic and therapeutic modalities available and thus, can help to individualize the treatment plan for each patient.

Sociodemographic Parameters of Esophageal Cancer in Northwest India: A Regional Cancer Center Experience of 10 Years.

BACKGROUND: Despite various advances in the treatment of Esophageal Cancer (EC), being one of the least responsive tumors to cancer therapy, the overall prognosis remains poor. Therefore, it is significant to understand various sociodemographic factors associated with EC to find out various schemes for primary prevention of the disease. MATERIALS AND METHODS: This is a retrospective analysis of medical records of the EC patients registered in the regional cancer center of northwest India from January 2003 to December 2012. The site of the disease and the histology were also recorded in addition to the various sociodemographic parameters. RESULTS: Out of 55,742 patients registered in our hospital; 3,667 were diagnosed to have EC. Male:female ratio was 1.15:1. The mean age was 54.6 ± 11.74 years; 66.15% of the patients were illiterate and 48.6% belonged to the low socioeconomic status. Smoking and alcohol consumption were identified as risk factors in 48 and 25.6% of the patients, respectively. CONCLUSIONS: The etiology in majority of the patients is linked to tobacco and alcohol, thus, modification of life style with limiting the use of addictions may be an effective strategy in the prevention of this dreaded and mostly incurable disease.

Isolated clival metastasis as the cause of abducens nerve palsy in a patient of breast carcinoma: A rare case report.

Metastatic lesions to the clivus have been reported in various cancers including lung cancer, prostate carcinoma, skin melanoma, and hepatocellular carcinoma. There have been only a few reports of breast cancer presenting with isolated clival metastasis. We report a case of 35-year-old lady, who was known case of breast carcinoma presented with diplopia as the only sign of clival metastasis. The etiology was established by magnetic resonance imaging which showed an enhancing lesion in the clivus. The diagnosis of clival metastasis from breast cancer was confirmed by transsphenoidal biopsy.

Cancer related fatigue: A ubiquitous problem yet so under reported, under recognized and under treated.

BACKGROUND: Cancer related fatigue (CRF) is a problem that is highly under reported, under recognized and thus, under treated. About 80% of patients receiving chemotherapy/radiotherapy experience CRF, making it the most common side effect of cancer treatment. Functional assessment of chronic illness therapy fatigue (FACIT-F) version-4 is a 13 item questionnaire that has been used to measure the level of fatigue of cancer patients during their daily activities over the past 7 days. MATERIALS AND METHODS: 92 patients of age 18 years and above attending the oncology Out Patient Department (OPD) of a regional cancer center were recruited in this study and were given FACIT-F questionnaire. The relevant sociodemographic parameters were obtained from the medical records of the patients. The internal consistency of the 13 items was measured using the Cronbach's alpha. RESULTS: The Cronbach alpha coefficient for FACIT-F scale in our study was found to be 0.74. Kendall's coefficient of concordance was estimated to be 0.080. The correlation between Eastern Cooperative Oncology Group (ECOG) performance status and mean score of FACIT-F was studied, Pearson correlation coefficient was estimated to be 0.271 (P = 0.009). CONCLUSIONS: FACIT-F is a brief, simple, easy to administer and patient friendly tool to measure the fatigue in last 7 days. CRF should be given adequate attention from the beginning of the treatment to improve the quality of life of cancer patients.

HMB-45 negative multifocal malignant perivascular epithelioid cell tumor of the soft tissue responding to sirolimus: First case report from India.

Perivascular epithelioid cell tumor (PEComa) is a group of sarcomas that exhibit a myomelanocytic phenotype and possess a unique cell type in the perivascular epithelioid cell. Traditionally HMB-45 immunoreactivity is the first criteria required to consider a tumor to be PEComa. We report a case of multifocal PEComa with negative HMB-45 marker. The patient presented with three big ulceroproliferative lesions; two over right thigh and one over the scalp in the right frontal region. The patient was prescribed with oral sirolimus to which good response was seen. To the best of our knowledge, this is the first case of HMB-45 negative multifocal malignant PEComa from India.

Diagnosis of post-radiotherapy local failures in nasopharyngeal carcinoma: a prospective institutional study.

BACKGROUND: This prospective study was conducted to evaluate and compare the efficacies of nasopharyngoscopy and CT scan in the diagnosis of local failure of external beam radiotherapy (EBRT) for nasopharyngeal carcinoma. METHODS: Total 52 patients of histopathologically proven nasopharyngeal carcinoma treated with external beam radiotherapy (EBRT), were included in this study. For every patient computed tomography (CT), nasopharyngoscopy and nasopharyngeal biopsies were performed 3 months after completion of EBRT. RESULTS: Three months after completion of EBRT, 9 patients (17.3%) had evident disease on histological examination of biopsies. Nasopharyngoscopy showed 77.78% sensitivity, 93.03% specificity, 70% positive predictive value and 95.24% negative predictive value in diagnosing the residual/recurrence of tumor. There was statistically significant agreement between the endoscopic findings and the histological findings (Kappa reliability coefficient=0.562, p<0.01). On the other hand, CT scan showed a 55.56% sensitivity, 39.53% specificity, 16.13% positive predictive value and 80.95% negative predictive value in diagnosing the residual tumor/recurrence. There was no statistically significant agreement between the CT scan findings and the histological findings (Kappa reliability coefficient = 0.038, p>0.05). CONCLUSION: Nasopharyngoscopy should be considered the primary follow-up tool after radiotherapy of nasopharyngeal carcinoma. CT scan should be reserved for patients with histological or any symptomatic indications. Routine postnasal biopsies are not required.

Double primary malignancies: a clinical & pathological analysis report from a regional cancer institute in India.

BACKGROUND: Patients which have diagnosed with a cancer, have a life time risk for developing another de novo malignancy depending on various inherited, environmental and iatrogenic risk factors. Cancer victims could survive longer due to settling treatment modalities, and then would likely develop a new metachronous malignancy.This article aims to report our observed trend of increasing, in prevalence of both synchronous and metachronous second primary malignancy, among the cancer victims, and to review the relevant literature. METHODS: A hospital based retrospective gathering of prospective data, among the patients that have diagnosed with second de novo malignancy.The study has conducted over a 4 years period from 2009 to 2012. All patients that have diagnosed with a histologically proven second malignancy as per Warren and Gates criteria have included. Various details which have regarded site, age at presentation, sex, synchronous or metachronous, treatment have recorded. RESULTS: Among 41 cases of multiple primary malignancies that have observed, 8 were synchronous (19.51%) and 33 were metachronous (80.49%). Out of 41 patients, 25 (60.98%) were females and 16 (39.02%) were males. The most common sites of primary tumor were head and neck cancers that have followed by gynecological cancers, breast cancer, lung cancer, esophageal cancer, and then the others. Among the second malignancy, the most common site was breast and gastrointestinal tract that have followed by lung and gynecological cancers. Out of the total number of cases with double location, 14 tumors (34.15%) have belonged to the breast, out of which 5 (12.20%) have represented first locations and 7 (17.07%) have been second locations. Both locations have belonged to the breast in 2 patients (4.9%). In 5 cases (12.20%), there were associations of breast-cervix and in 6 cases (14.63%), there were association of lung-head & neck cancers. CONCLUSION: The incidence of multiple primary malignancies has not been rare at all. Screening procedures have especially been useful for the early detection of associated tumors, whereas careful monitoring of patients has treated for primary cancer, and then a good communication between patients and medical care team would certify not only an early detection for secondary tumors, but only finally & subsequently, an appropriate management.

A case of CD68 negative histiocytic sarcoma of axilla masquerading as metastatic breast cancer.

Histiocytic sarcoma is a malignant proliferation of cells showing morphological and immunophenotypic features of mature tissue histiocytes. Most of the cases in the literature have reported CD68 positivity. We report a case of histiocytic sarcoma whose presentation mimicked a metastatic breast cancer. A 40-year-female patient presented with a 13 × 11 cm left axillary mass in close proximity to the left breast. Tru-cut biopsy from the lesion suggested the diagnosis of a lymphoid neoplasm. Complete excision of the axillary mass was done. On simple microscopy, numerous mature small lymphocytes were seen dispersed in the follicles. Immunohistochemistry revealed CD31- and CD163-positive cells, which stained negative for CD68, CD1a, cytokeratin and S100; thus, confirming the diagnosis of histiocytic sarcoma.