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Summary Objective Overexpression of epidermal growth factor receptor (EGFR) in many cancers makes it an attractive therapeutic target. This study evaluated the clinical utility of nimotuzumab, a monoclonal anti-EGFR antibody, used concurrently with radiotherapy (RT) and chemoradiotherapy (CRT) in squamous cell carcinoma of the head and neck (SCCHN). Methods This open-label study randomized 92 treatment-naive patients (1:1) with advanced SCCHN into chemoradiation (CRT ± nimotuzumab) or radiation (RT ± nimotuzumab) group by investigator’s discretion; these were further randomized into CRT + nimotuzumab or CRT and RT + nimotuzumab or RT groups, respectively. Treatment included 6 cycles each of cisplatin (50 mg/week), nimotuzumab (200 mg/week), and RT (total dose, 60–66 Gy). Response (tumor size reduction) was assessed at Month 6 post-treatment and survival, at Month 60. Results Forty and 36 patients in the chemoradiation and radiation groups, respectively (intent-to-treat population) were evaluated. Overall response at Month 6 post-treatment was 100% with CRT + nimotuzumab, 70% with CRT, 76% with RT + nimotuzumab, and 37% with RT. At Month 60, overall survival was 57% with CRT + nimotuzumab, 26% with CRT ( P = 0.03), 39% with RT + nimotuzumab, and 26% with RT ( P > 0.05). Median overall survival was not reached for CRT + nimotuzumab; it was 21.94 months for CRT ( P = 0.0078), 14.36 months for RT + nimotuzumab, and 12.78 months for RT ( P = 0.45). Risk of death was 64% lower with CRT + nimotuzumab than with CRT (95%CI: 0.37, 1.56), and 24% lower with RT + nimotuzumab than with RT (95%CI: 0.16, 0.79). Thus nimotuzumab was safe and well tolerated with few mild to moderate self-limiting adverse events. Conclusion Concurrent use of nimotuzumab with CRT/RT is safe and provides long-term survival benefit.

Introduction Breast Cancer is the second common cancer among women in India and nearly 21% of the women, who develop the disease, die within the first year of diagnosis. Lack of awareness and facilities for early detection and treatment are some of the reasons for this. The rural field Practice area of a tertiary care teaching hospital is the setting for this study wherein a community based intervention was initiated to promote breast cancer screening among rural women. The study also tried to identify the awareness, perceptions & attitude towards breast cancer & mammography use among these women. Methods Breast cancer educational sessions were conducted by trained health workers. Women were later contacted at their homes and invited to attend a CBE and mammography at the tertiary care centre at no cost. Those willing were provided transportation as well as assistance to attend the screening session. Results A total of 599 women were screened over a span of 2 years (response rate −85%). Most of the participants were in the 40–50 age group (59.8%). Seventy nine per cent were unaware regarding the risk factors for breast cancer and nearly 60% were not aware of any breast cancer screening methods. Only 16% had heard of mammography earlier. Anxiety, pain and cost factor were some of the perceived barriers for mammography. Conclusion In spite of poor awareness regarding breast cancer & it9s screening modalities participation was encouraging, demonstrating that a targeted intervention could bring about the required health seeking behaviour.

5530 Background: h-R3mAb (nimotuzumab) is a humanized monoclonal antibody targeting epidermal growth factor receptor (EGFR). EGFR is over-expressed in >90% squamous cell carcinoma of head and neck (SCCHN). Patients with advanced inoperable SCCHN have poor outcome to radiotherapy (RT) or chemoradiotherapy (CRT) treatment alone. Adding biologically active targeted therapies to RT/CRT might further improve therapeutic outcome with minimal morbidity. Methods: Total of 113 patients with (stage III or IVa), inoperable SCCHN were screened; 92 randomized in 1:1 ratio in two groups; group A received [RT Vs RT+h-R3mAb] and group B received [CRT vs. CRT+h-R3mAb]. Treatment included radiotherapy in total dose 60 -66Gy, h-R3mAb 200mg by I.V infusion over 60 min/ week for 6weeks and in group B, chemotherapy CDDP 50mg/week for 6weeks. Results: Seventy-six patients were evaluable; 36-groupA and 40-groupB. Locoregional response was 100% in CRT+h-R3mAb vs. 70% in CRT and 76% in RT+h-R3mAb vs. 37% in RT. At 48 months follow...

Changing trends and adoption of information and communication technology (ICT) in healthcare settings have equipped modern healthcare providers a method to resolve their day to day challenges in enhancing quality decision making and patient care. Breast cancer is one of the leading causes of death globally. The control and prevention of it is largely depends on instant access and availability of patients information and domain knowledge to the clinicians. Unavailability or delay in receiving this information leads to medical error, unnecessary complications and suffering to the patient. As an important application of Information and communication technology, Clinical Decision Support System supports the clinicians in providing easy and instant access of accurate, complete and adequate patient's information and domain knowledge for quality decision making, reducing medical errors and promoting evidence based practice. This paper focuses on the design, development and implementation of a Novel Knowledge Based Decision Support System model in breast cancer treatment for improving the accessibility of domain specific clinical data for faster and more efficient use. Key word: Clinical decision support system, breast cancer, Information and communication technology Sri Lanka Journal of Bio-Medical Informatics 2010; 1 (2):97-103. DOI: 10.4038/sljbmi.v1i2.1609

6041 Background: Patients (pt) with advanced inoperable squamous cell carcinoma of the head and neck (SCCHN) have poor radiotherapy alone (RT) outcome. EGFR is over-expressed in >90% SCCHN. h-R3mAb (BIOMAb/nimotuzumab/TheraCIM) is a humanized monoclonal antibody, a validated oncotherapeutic-targeting EGFR. Objective: To investigate the safety and efficacy of concurrent h-R3mAb in combination with chemoradiotherapy of SCCHN. Methods: September 2004–2005, pt 18–70 yrs, SCCHN stageIII-IVA, 113 screened, 92 enrolled and randomly asssigned to, Group A: radical radiotherapy (pt) and Group B: chemoradiotherapy (pt). Randomization within Group A: [RT]v/s[RT+h-R3mAb] and within Group B: [RT+CT]v/s[RT+CT+ h-R3mAb] (n = 23 in each arm). Protocol: Radiotherapy: TD: 66 Gy,2Gy/Fr,5Fr/w,6.5wks. Radiation sensitizer (chemotherapy): CDDP-50mg/wk x 6wks. Study Drug (h-R3mAb): 200 mg/wk I.V.60min x 6weeks. Results: Evaluable (n = 76) in Group A-36 and Group B-40. F/u Analysis at 30 months after end of RT. Survival rate ITT: Group B: CT+RT+hR3- 69.5% v/s CT+RT-21.7% (p - 0.0011), Group A: RT alone - 21.7% v/s RT+ hR3–39.1% (ns). Progression-free survival: RT alone - 3(13.04 %) v/s RT+hR3mAb-8 (34.78 %), RT+CT-5 (21.74 %) v/s RT+CT+hR3mAb-13 (56.52%). Median overall survival (OS): CT+RT+hR3 - NR* v/s CT+RT- 21.96 months (hazard ratio [HR]-0.337, p - 0.0018) and RT alone - 25.02 v/s RT+hR3 - NR*(HR-0.678, p - 0.39). Disease-free survival: CT+RT+hR3- NR*v/sCT+RT-21.30 mths (HR-0.344, p - 0.0052) and RT alone-25.02 v/s RT+hR3- NA* (HR-0.599, p - 0.32). (NR*- median OS is yet to be reached). Safety: few grade - 1/2AE, no HAMA observed. OS per protocol - adding h-R3mAb to chemoradiation resulted in a reduction in risk of death (rrd) by 85% (HR 0.15, p - 0.0006) and to RT a 36 % rrd (HR0.64, p - 0.33). Conclusions: Concurrent use of h-R3mAb with RT or RT+CT is safe and efficacious. It enhances radiation and chemotherapy responses. Concurrent use of h-R3mAb with chemoradiotherapy enhances long-term loco-regional control and survival. Adding biological agents to physically targeted modality improves long-term therapeutic outcome of SCCHN. No significant financial relationships to disclose.

Radiologic examination plays a crucial role in the evaluation of suspected gastrostomy complications. This has not been stressed adequately in the radiologic literature. In a retrospective review of 230 patients who underwent tube gastrostomy for varied clinical conditions, 70 patients who had radiologic examination for evaluation of gastrostomy-related complications were identified. Thirty complications were diagnosed radiologically. There were 11 gastric obstructions, 11 tube displacements, four gastric ulcers, two gastric perforations, one leaking gastrostomy, and one broken gastrostomy tube. Gastric torsion and gastric pneumatosis are reported for the first time as complications of gastrostomy.