Positron emission tomography thyroid incidentaloma: Is it different in Indian subcontinent.

BACKGROUND: Positron emission tomography (PET) forms an integral part in work‑up and follow‑up of various malignancies. With the increased use of PET in oncology, finding of an incidental focal thyroid uptake (incidentaloma) is not unusual and presents a diagnostic challenge. AIM: The aim of the following study is to evaluate the frequency and radio‑pathologic correlation of focal 18‑fluoro deoxyglucose uptake (FDG) on PET within the thyroid from a large series. MATERIALS AND METHODS: Retrospective review of 37,000 consecutive patients who underwent FDG‑PET at tertiary cancer center in India. Radiological, pathological, PET scan and follow‑up details were evaluated. Statistical analyzes were carried out using Mann Whitney test and Pearson correlation. RESULTS: Abnormal thyroid uptake was seen in 78 (0.2%) patients. Nearly 61 (0.16%) scans had focal and 17 (0.04%) had diffuse FDG uptake. A total of 57 patients with focal uptake were available for further evaluation. No further evaluation was done in 24 (42.1%) patients who had advanced index malignancy. Of the remaining 33 patients 26 were benign and seven were a cause for concern (four primary thyroid cancers, one follicular neoplasm with hurthle cell change and two metastatic cancers). There was no significant correlation in Standardized uptake value (SUV) max of benign and malignant lesion (P = 0.5 on Mann Whitney) or size (r = 0.087 Pearson correlation co‑efficient P = 0.667). CONCLUSION: Incidence of PET incidentaloma is low in this large cohort of Indian patients. Nearly 27% of focal incidentaloma were malignant. There was no correlation between the SUVmax, size and malignancy.

Barriers in conducting clinical trials in oncology in the developing world: A cross‑sectional survey of oncologists.

BACKGROUND: Several obstacles impede oncologists from performing clinical trials in the developing world. This study aimed to identify these barriers in order of importance and suggest possible remedial measures. MATERIALS AND METHODS: Design – cross‑sectional survey. Two part questionnaire capturing experience of oncologists in practice and conducting trials (Part 1) and perceived barriers pertaining to investigator (training, time), patient (strict follow‑up protocol), infrastructure (funds) and professional environment (encouragement from seniors) (Part 2) were administered to oncologists in two different settings: (1) Online portal (Survey Monkey) (2) In person during a national conference (Best of American Society of Clinical Oncology). Responses were captured on a Likert scale (1–5). RESULTS: (436/3021) 14.04% responded. A total of 313 (71.8%) had experience in conducting trials, but these were mainly industry‑sponsored or small nonpractice changing studies. Lack of patient follow‑up was the most significant barrier (inter quartile range [IQR] 4–5) followed by inadequate training, time and funds (IQR 2–5) and lack of encouragement (IQR 2–4) in decreasing order of frequency. Lack of adequate training was a barrier across all specialties (113 [71.97%] radiation oncologists, 71 [60.68%] medical oncologists and 73 [71.56%] surgical oncologists). More than half of the respondents without experience in clinical trials worked in academic institutions (50.48%). They perceived time constraint as a barrier more than their counterparts into private practice (175/242 [72.31%] vs. 119/177 [66.47%] respectively). CONCLUSION: Inability to maintain patient follow‑up, lack of protected time and funds, inadequate training were the most significant barriers. Most of these can be addressed.

Microbial colonization of Provox voice prosthesis in the Indian scenario.

INTRODUCTION: Tracheoesophageal speech using the voice prosthesis is considered to be the “gold standard” with success rates as high as 90%. Despite significant developments, majority eventually develop dysfunction due to microbial deterioration. We did a pilot study of 58 laryngectomy patients who developed prosthesis dysfunction. MATERIALS AND METHODS: A total of 58 laryngectomy patients who had their dysfunctional prosthesis removed were included in this study. Dysfunctional prostheses were removed and examined. Esophageal and tracheal flanges were examined separately. After obtaining pure fungal and bacterial cultures, the yeast strains were identified. Bacteria were identified with the light microscope and gram staining. We analyzed prosthesis lifespan and probable factors affecting it. RESULTS: Central leak was found in 43% cases while in 57% peri‑prosthetic leakage was the most common reason for prosthesis replacement. Microbial analysis revealed a combination of yeast and bacteria in approximately 55% culture samples. Out of these, almost 90% had the presence of single yeast species with bacteria. Pure fungal culture was identified in rest of the 45% cultures while none detected pure bacterial forms. Candida tropicalis was the solitary yeast in 81% while Candida albicans was seen in 10% as the solitary yeast. Bacterial isolates revealed Klebsiella pneumonia in 19%, Escherichia coli in 8% while Staphylococcus aureus was grown in 1% cultures. The consumption of curd (P = 0.036, 95% confidence intervals [CI]: 2.292‑64.285) to have a significant correlation of the mean prosthesis lifespan. Consumption of curd (P = 0.001, 95% CI: 0.564‑2.008) and history of prior radiotherapy (P = 0.015, 95% CI: 0.104‑0.909) had a significant bearing on the Provox prosthesis lifespan. CONCLUSIONS: Candida is the most common organism grown on voice prosthesis in Indian scenario. Consumption of curd and history of prior radiotherapy significantly affect Provox prosthesis lifespan.

Delay in seeking specialized care for oral cancers: Experience from a tertiary cancer center.

OBJECTIVE: Advanced oral cancers are a challenge for treatment, as they require complex procedures for excision and reconstruction. Despite being occurring at a visible site and can be detected easily, many patients present in advanced stages with large tumors. Timely intervention is important in improving survival and quality of life in these patients. The aim of the present study was to find out the causes of delay in seeking specialist care in advanced oral cancer patients. MATERIALS AND METHODS: A prospective questionnaire based study was done on 201 consecutive advanced oral squamous cancer patients who underwent surgery at our hospital. All patients had either cancer of gingivobuccal complex (GBC) or tongue and had tumors of size more than 4 cm (T3/T4) and were treatment naïve at presentation. RESULTS: Even though most patients observed abnormal lesions in their mouth, majority delayed the decision to visit a physician early. A significant percentage of patients (50%) also reported a delayed diagnosis by the primary care physician before being referred to a tertiary care center for definitive treatment. The average total duration from symptoms to treatment was 7 months. CONCLUSION: The main reasons of this delay in receiving treatment were due to patients themselves (primary delay) or due to time taken by the primary physician to diagnose the condition (secondary delay). Oral self-examination can be helpful in detecting oral cancers early.

Neo-adjuvant chemotherapy in advanced hypopharyngeal carcinoma.

Objective: The aim of this retrospective study was to find out the role of neo-adjuvant chemotherapy (NACT) in changing the management and outcome of advanced hypopharyngeal cancer patients. Materials and Methods: This is a retrospective analysis of 59 treatment naïve, advanced hypopharyngeal cancer patients presenting to our tertiary care center from April 2010 to October 2011. NACT was given as two (platinum with taxane) or three drug with (platinum, taxane with 5-flurouracil [5 FU]) as 3 weekly regimen with cisplatin and docetaxel as 75 mg/m 2 each, 5-FU as 1000 mg/m 2 . NACT was either given with the intent of achieving: (1) surgical resection (extensive soft tissue disease, oropharyngeal involvement, extensive disease with cartilage erosion) or (2) organ preservation (Bulky disease with inner cartilage erosion, exolaryngeal disease without cartilage erosion, large N3 nodes). Results: The mean age of this population was 55 years. Most (83%) of the patients had pyriform sinus (PFS) involvement. 69% patients had Stage IVa disease, 21% Stage IVb and 10% Stage III. The overall response rate was 66%, including 06% complete responses and 60% partial responses. Following NACT, resectability was achieved in 30% (10/33) and organ preservation protocol was planned after NACT in 73% (19/26) patients. The main toxicities were neutropenia (grade 3, 4, 04%; febrile neutropenia, 4%), mucositis 5%, diarrhea 5%. The median progression free survival was 20 months. Conclusions: NACT can be useful in patients with oropharyngeal involvement to achieve surgical resection and larynx preservation in patients with bulky T3 disease.

Utility of PET in unknown primary with cervical metastasis: A retrospective study.

Background: FDG-PET is recommended as an investigation in unknown primary tumors, but its definitive role and cost effectiveness are yet to be established. Aims: dditional value of FDG-PET over conventional imaging in unknown primary tumors with cervical metastasis. Setting and Design: Retrospective study in a tertiary level oncology centre. Materials and Methods: A total of 112 patients were divided into three groups; 53 with conventional modalities (either computed tomography or magnetic resonance imaging) (group I), 59 with FDG-PET (group II), and group III (subgroup of group II) with both (40 patients). Statistical Analysis: Sensitivity and specificity of both conventional modality and PET were calculated. Association between neck nodes and distant metastasis was analysed using multivariate logistic regression analysis. Results: Sensitivity and specificity for conventional modalities was 92.3% and 50% and sensitivity and specificity of FDG-PET was 92.8% and 71.4%, respectively. FDG-PET detected metastasis in 52.54% of patients. Multivariate logistic regression analysis showed statistically significant association between distant metastasis and multiplicity of nodes (N2b, N2c) (P = 0.007). Among all patients with low neck nodes in group II, FDG-PET detected primaries in 12 patients, 9 of which were infraclavicular (75%). FDG-PET added information to conventional imaging in 32.5% of patients and influenced an overall change in management in 38.9% of patients. Conclusions: FDG-PET is a valuable tool influencing change of management in unknown primary with cervical metastasis. It is recommended especially in the presence of low or multiple neck nodes in view of high incidence of infraclavicular primary and distant metastasis, respectively.

Cetuximab with radiotherapy in patients with loco-regionally advanced squamous cell carcinoma of head and neck unsuitable or ineligible for concurrent platinum-based chemo-radiotherapy: Ready for routine clinical practice.

Purpose : To report outcomes of cetuximab concurrent with radiotherapy in advanced head-neck cancer unsuitable for platinum-based chemo-radiotherapy. Materials and Methods : Retrospective chart review of 37 patients treated with cetuximab and radiotherapy at a comprehensive cancer centre. Results : Median age of study cohort was 59 years. Thirty four (92%) patients had advanced stage disease (stage III-IV). Reasons for ineligibility for platinum included impaired creatinine-clearance, old age, and/or co-morbidities. Thirty-two (86%) patients completed planned radiotherapy without interruption; 29 (80%) patients received ≥6 cycles of cetuximab. Fifteen patients (40.5%) developed ≥grade 3 dermatitis; 9 patients (25%) experienced ≥grade 3 mucositis. At a median follow-up of 16 months, the 2-year loco-regional control, disease-free survival, and overall survival was 35.5%, 29.5%, and 44.4% respectively. Stage grouping and severe dermatitis were significant predictors of outcome. Conclusions : Cetuximab concurrent with radiotherapy is a reasonable alternative in advanced head-neck cancer patients with acceptable compliance and outcomes, but higher skin toxicity.

In vitro chemosensitivity profile of oral squamous cell cancer and its correlation with clinical response to chemotherapy.

CONTEXT: Oral cancers represent a disparate group of tumors with diverse clinical behavior and chemosensitivity profile. Currently, it is difficult to predict whether a tumor will respond to chemotherapy and which drug(s) will achieve the maximum clinical response. AIMS: To study in vitro chemosensitivity profile of oral cancers and to correlate the in vitro chemosensitivity of oral cancer to clinical response to chemotherapy. SETTINGS AND DESIGN: Prospective study in a tertiary cancer care center. METHODS AND MATERIAL: We prospectively studied the chemosensitivity profile of 57 untreated, advanced, unresectable oral cancers to cisplatin, methotrexate, 5-fluorouracil and their combinations by using histoculture drug response assay (HDRA) and correlated them to the clinical response to chemotherapy. STATISTICAL ANALYSIS USED: Chi Square test. RESULTS: Biopsy samples were successfully histocultured in 52/57 (91%) cases. Of these 52 evaluable patients, 47 had primary gingivo-buccal cancers and five had tongue / floor of mouth cancers. Based on the assay, 27 (52%) tumors were sensitive to cisplatin, 27 (52%) to methotrexate, 24 (46%) to 5-fluorouracil, 38 (73%) to combination of cisplatin and methotrexate and 36 (69%) to combination of cisplatin and 5-fluorouracil. Of these, 31 patients with good performance status received two cycles of chemotherapy using one or more of these test drugs. There was a significant correlation (p=0.03) between the in vitro chemosensitivity and the clinical response. Negative predictive value of the test was 80%, positive predictive value-69%, sensitivity-79% and specificity -71%. The overall accuracy of the assay was 74%. CONCLUSIONS: We found HDRA to be a fairly good predictor of chemo-response of oral cancer.

Validation of the University of Washington quality of life questionnaires for head and neck cancer patients in India.

Quality of life (QOL) is a multidimensional construct capturing the subjective wellbeing of patients in physical, emotional, functional and social domains. Available work on post treatment QOL have only been made in western literature and less in Indian literature. AIMS: To translate the UW-QOL into both Hindi and Marathi and psychometrically validate the translation in HandN cancer patients in Indian population. SETTINGS AND DESIGN: A prospective study was done at the Tata Memorial Hospital for patients who were treated for H and N cancers. MATERIALS AND METHODS: 147 patients were enrolled from January to April 2005. The study was carried out in two phases. Patients were given translated versions of the UW-QOL and EORTC QOL questionnaires pre-operatively, 15 days post-operatively and then three months post-operatively. RESULTS: Both the Hindi and Marathi translations had strong internal consistency (Cronbach's alpha=0.7971 and 0.7839). UW-QOL composite scores correlated well with the global questions on overall QOL in both the Hindi (r=0.69) and Marathi (r=0.66) translations and also with T-stage. QOL scores were worse three months post-operatively than pre-operatively and for patients undergoing surgery that violated the mucosa. A strong correlations was observed (r>0.50) between all similar domains on the UW-QOL and EORTC HandN35 except the saliva item on the Marathi translation, where r< 0.50, but P-values were significant. CONCLUSIONS: The Marathi and Hindi versions of the UW-QOL appear to be valid and reliable instruments for assessing the QOL in Indian population and will be a vital tool for achieving greater insight into the short- and the long term QOL.

Quality of life of head and neck cancer patient: validation of the European organization for research and treatment of cancer QLQ-C30 and European organization for research and treatment of cancer QLQ-H&N 35 in Indian patients.

AIMS: To present the first cross-culture validation of the European organization for research and treatment of cancer (EORTC) quality of life questionnaires, the EORTC-QLQ-C30, and the QLQ-H&N 35 in India. SETTINGS AND DESIGN: These questionnaires were translated into two vernacular languages and pilot test was done on 15 patients. Two hundred head and neck cancer patients completed the QLQ-C30 and the QLQ-H&N 35 at two time points during their treatment. Psychometric evaluation of the structure, reliability, and validity of the questionnaire was undertaken. RESULTS: The data supports the reliability of the scales. Validity was tested by item-scale, scale--scale correlation and by performing known group comparisons. The results demonstrated that the items correlated with their respective scale and no significant correlation was found between scales. The questionnaire was responsive to change over a period of time. SUMMARY: This data suggests that the EORTC QLO-C30 and the QLQ-H&N 35 are reliable and valid questionnaires when applied to a sample of head and neck cancer patients in India.

A prospective study of pharyngocutaneous fistulas following total laryngectomy.

Pharyngocutaneous (PC) fistula is a common complication following laryngectomy. It leads to increased morbidity, delay in adjuvant treatment, prolonged hospitalization and an increase in treatment costs. Although a number of factors that result in PC fistula have been described, there is still no agreement on the most significant factors. We undertook a prospective study to critically analyze PC fistula and its association with various tumors, patient and treatment related factors. This was a prospective study that included 143 patients who underwent laryngeal surgery for squamous cell carcinoma of the larynx and pyriform sinus. Use of pectoralis major myocutaneous flap to reconstruct the neopharynx, primary disease in pyriform and extensive soft tissue infiltration were significantly associated with PC fistula. Prior treatment (radiotherapy and chemotherapy), type of closure (T closure, Y closure and vertical closure), Layers of closure (full thickness interrupted, submucosal interrupted, submucosal continuous) type of suture material (silk, vicryl ), age, sex, stage, preoperative tracheostomy, cut margin status, pre/postoperative hemoglobin and experience of surgeons did not relate significantly.