Dear
,
Thank you for reaching out to Tata Memorial Centre (TMC) and nationally acclaimed experts of the National Cancer Grid (NCG). Navya is pleased to offer this online expert cancer consultation service for assessing your treatment options. We converted your case reports into a structured summary to be reviewed by a nationally renowned medical oncologist trained at Tata Memorial Centre, and formerly a member of the Gastro Intestinal Disease Management Group at Tata Memorial Centre. We asked the following question(s) on your behalf: What is recommended at this time: chemotherapy with Everolimus or an alternate treatment? The TMC NCG Navya opinion is summarized as follows: 1. Given that the Ki67 value is less than 30%, Peptide Receptor Radionuclide Therapy (PRRT) (i.e. a form of targeted therapy, which is performed by using a small peptide (A Somatostatin analog similar to Octreotide) that is coupled with a radionuclide emitting beta radiation) is recommended at this time. 2. Additionally, along with PRRT (as mentioned above), given the presence of dota and FDG avidity (as mentioned in the structured summary), chemotherapy with Capecitabine is recommended at this time. We hope that the expert opinion is helpful in determining the course of your treatment. Please discuss this opinion with your treating oncologist(s). Navya Evidence and Experience Engine is used to assess treatment options derived from clinical trials that pertain to your specific medical history and tumor characteristics as well as analysis of tumor board decisions of patients similar to you treated at internationally renowned tertiary care expert centers. Navya is pleased to provide the following information on treatment recommendation(s) per the Navya Evidence Engine, which includes the globally accepted guidelines for the treatment of cancers by National Comprehensive Cancer Network (NCCN); and the Navya Experience Engine based on the collective experience of experts at Tata Memorial Center and the National Cancer Grid. This TMC NCG Online Expert Opinion Service, and Navya Network Inc., does not diagnose, treat, give orders, or have the ultimate authority over the care of any individuals. Page 1
1. Chemotherapy with Capecitabine 1000 mg/m2 twice daily from day one to day 14 every three weeks (i.e. in a 21 day cycle) until disease progression or dose limiting toxicity is recommended. 2. After completing every three cycles of the recommended chemotherapy with Capecitabine, assessment of response (i.e. whether the tumor(s)/lesion(s) in the body have decreased/not increased/increased) with ultrasound/CT scans with oral and iv contrast of the chest/abdomen/pelvis or PET CT scan of the whole body is recommended. Further, we are pleased to provide the following information and responses to your question(s). For your convenience, we have reproduced your question(s) in italics and within quotes. 1. “What is normal life expectancy? How does this tumour behave? Through this cancer online consultation service, we cannot provide direct responses on curability of a disease or life span of a patient. However, following the recommendations in the expert opinion above, in consult with and under the care of your treating oncologist(s), provides a strong path forward in managing your clinical diagnosis at this time. 2. “What health issues will be noted in the coming days? How does it affect the working and body of the person?” Please note that the list of side effects for any cancer medication is long. These medications are only recommended by expert oncologists when the benefit from controlling the cancer and improving quality of life is greater than the risk of suffering from the side effects listed below. Further, medications to control common side effects may be administered by your treating oncologist. When reviewing the list of side effects given below, it is important to keep in mind that the benefit of the medication generally applies to everyone, while your experience of treatment may not include many of the following reported side effects. The common side effects associated with administering, severe nausea or vomiting (may be severe), stomach pain or upset, loss of appetite, constipation, tiredness, weakness, back/joint/muscle pain, headache. For additional questions) regarding information for associated side effects to treatment, consultation with your treating oncologist/physician is recommended, who are best suited to provide information on above mentioned question(s).
This TMC NCG Online Expert Opinion Service, and Navya Network Inc., does not diagnose, treat, give orders, or have the ultimate authority over the care of any individuals. Page 2
If your treatment plan involves complex details such as a choice of immunotherapy vs targeted therapy or enrollment in a clinical trial or bone marrow transplant, etc., please write to us at reports@navya.care We will prioritize a response based on clinical urgency as it pertains to your receiving on time care. Questions on managing ongoing side effects of cancer treatments such as pain, mouth sores, fever, infection, bleeding, etc. are only suited for in person examination with your local treating oncologist(s)/physician(s). These questions are not amenable to an online expert review. Navya is focused on assessing your cancer treatment options. If you are a financially underprivileged patient or receiving treatment under the General Category of any hospital, please reach out to us after you complete your current therapies (surgery or chemotherapy or radiation, etc.) We will assess your treatment response and continue to provide your next treatment plans at no cost. Please do not hesitate to write to us or call us with any questions.
Sincerely, Gitika Srivastava
This TMC NCG Online Expert Opinion Service, and Navya Network Inc., does not diagnose, treat, give orders, or have the ultimate authority over the care of any individuals. Page 3
CASE SUMMARY
Expert Opinion ID
Current Diagnosis: Metastatic Neuroendocrine Tumor Of Colon Age: 74 Years Old Gender: Male Past Medical History: Diabetes Type 2 Past Medical History: Hypertension (High BP) First Presentation: May 2016 Complaint(s): Severe abdominal pain, colicky, non radiating, h/o loose motion for four months associated with weight loss [May 2016] CT Abdomen/Pelvis: 4*1.6 cm Rt proximal ascending colon enhancing mural thickening starts beyond ileocaecal junction infiltrating medial pericolonic fat and mild thickening of adjoining posterior peritoneal lining- ?Colon Ca; 2.1*1.4 cm enlarged pericolic LNs [May 7th 2016] Prior Surgery #1: Timing
Surgery
Surgery Date
Primary
Laparoscopic Right Hemicolectomy
May 9th 2016
Surgery Note: 9*6 cm mass involving caecum & ascending colon, adherent to peritoneum, regional lymphadenopathy, no distant mets Pathological Tumor Size (cm): 4.0*3.5*1.5 Final Margins- Surgery: Negative (>10 mm) Number Of Regional Pathological Lymph Nodes Positive/Resected: 5/7 Malignant Disease: Adenocarcinoma Note: Neuroendocrine differentiation This TMC NCG Online Expert Opinion Service, and Navya Network Inc., does not diagnose, treat, give orders, or have the ultimate authority over the care of any individuals. Page 4
Cancer Grade: II Peri Neural Invasion: No Lymphovascular Invasion: Positive Note: Tumor invades entire wall thickness MIB- 1: 3 % IHC- Positive: Synaptophysin, Chromogranin [June 4th 2016] Chromogranin A: 420 (High) [June 9th 2016] DOTANOC PET- CT: Post surgical changes; subcm Rt lower paratracheal & subcarinal calcified LNs; no evidence of metastatic disease elsewhere in the body [July 29th 2016] Chromogranin A: 165 (High) [July 30th 2016] Chromogranin A: 80 (High) [October 28th 2016] Second Presentation: [December 2016] Complaint(s): Mild abdominal pain, weakness [December 2016] CT Abdomen/Pelvis: 1.6*1.5 cm seg IV liver lesion; multiple 4.2*3 cm Rt paracolic deposits with small omental, mesenteric & pelvic deposits- Mets; 3.0*2.4 cm enlarged necrotic aortocaval LNs- Mets [January 1st 2017] Diagnosis Made By: Slide/Block review- Surgical Pathology [January 23rd 2017] Malignant Disease: Adenocarcinoma Note: Neuroendocrine differentiation Cancer Grade: II Note: Tumor infiltrating the entire thickness of the ceacum and is extending into the adjacent fat Number of Pathological Lymph Nodes Positive/Resected: 5/7 This TMC NCG Online Expert Opinion Service, and Navya Network Inc., does not diagnose, treat, give orders, or have the ultimate authority over the care of any individuals. Page 5
Perinodal Extension: Yes Lymphovascular Invasion: Positive Peri Neural Invasion: Yes Chromogranin A: 325 (High) [January 27th 2017] DOTATATE/FDG PET- CT: 6.8*3.7*3.2 cm Rt perinephric mesenteric mass with perilesional stranding (SUV-4.4 on DOTATATE; SUV-17.5 on FDG), abutting ileal loops & Rt posterolateral abdominal wall muscles with ill defined fat planes- new lesion; 4.0*3.1 cm Rt hemipelvis mass with perilesional stranding (SUV-3.4 on DOTATATE) abutting Rt iliacus muscles with ill defined fat planes- new lesion; 2.2*1.9 cm mesenteric deposit, abutting pancreatic uncinate process & duodenal D3 with ill defined fat planes; 5.3*2.1 cm pelvic & recto- vesical pouch mesenteric ill defined deposit (SUV-4.6 on DOTATATE; SUV-17.4 on FDG)- New; 1.8*1.5 cm Lt inguinal canal soft tissue lesion. 3.1*2.1 cm L1 vertebral aortocaval LNs (SUV-17.4 on FDG); subcm Rt lower paratracheal, AP window, subcarinal & b/l hilar LNs; FDG avid- Rt peripheral prostate zone with few FDG avid Rt periprostatic nodular lesions. 1.8*1.3 cm seg VI, V, VI, VIII liver lesion- no uptake. Prostatomegaly [January 30th 2017] PSA: 0.9 [February 3rd 2017] Diagnosis Made By: Biopsy- Right Paracolic Gutter Tissue [February 7th 2017] Malignant Disease: Neuroendocrine Carcinoma Cancer Grade: III IHC- Positive: CK 7, CK20 (Diffuse), Synaptophysin (Diffuse), Chromogranin (Diffuse), CDX2 IHC- Negative: TTF-1 Ki- 67: 20-25% Note: Primary gastrointestinal tract Clinical TNM Stage: Stage IV- any T any N any M Bone Marrow (Hematologic) Function: Adequate [January 26th 2017] This TMC NCG Online Expert Opinion Service, and Navya Network Inc., does not diagnose, treat, give orders, or have the ultimate authority over the care of any individuals. Page 6
Kidney (Renal) Function: Adequate [January 26th 2017] Liver (Hepatic) Function: Adequate [January 26th 2017] Heart (Cardiac) Function : Not done General Condition: Patient has generalized weakness, mild abdominal pain on/off. However, capable of all self care activities Functional Status- ECOG Score: 0-1 Note: Patient/caregiver understands the risk factor of age and complexity of an online opinion based on above facts alone, yet desires the online opinion
This TMC NCG Online Expert Opinion Service, and Navya Network Inc., does not diagnose, treat, give orders, or have the ultimate authority over the care of any individuals. Page 7
Navya is a Cambridge, MA based company with offices in Bangalore, India. Navya is founded by graduates of Harvard University, MIT Sloan School of Management, and the Stanford School of Medicine. Navya’s innovative and scalable decision-making system is a technology powered solution for complex medical questions. Navya’s software solutions are efficient engines to gather and synthesize individual goals of care, evidence specific to an individual medical case, and expert opinion, for evaluating treatment alternatives. Navya’s goal is to assist in bringing clarity to the complexity of evaluating treatment alternatives. Navya’s system collects the best available information and expertise from several worldwide sources relevant to a specific previously diagnosed medical case and assesses treatment decisions. For more information, please visit www.navya.care or call +91 80-61787700 or email gitika@navya.care Navya Network, Inc does not diagnose, prescribe medication, treat, or give orders, nor does Navya have the ultimate authority over the care of any individuals. Navya does not provide medical advice nor does its products, services, systems, projects, or programs constitute the practice of medicine, nursing, or any other health care profession. Any information provided by Navya as a result of use of Navya’s products, services, systems, projects, or programs is being provided solely for educational and informational benefit and should not be considered diagnosis, treatment or a substitute for professional medical advice. Use of Navya’s products, services, systems, projects, or programs does not establish a doctor-patient relationship. Navya encourages that individuals or patients using Navya’s products, services, systems, projects, or programs share any reports or other information generated by the use of Navya’s products, services, systems, projects, or programs with their treating health care provider. Use of Navya’s products, services, systems, projects, or programs is voluntary and any information communicated as a result of the use of Navya’s products, services, systems, projects, or programs is not intended to be, nor implied to be, and cannot and should not be used as a substitute for professional medical advice, diagnosis or treatment. Navya’s products, services, systems, projects, or programs are limited to the provision of consultative services with respect to known or previously-identified condition and neither Navya Care, nor its employees, consultants or agents with whom it contracts will diagnose, treat, give orders, prescribe medications or have any authority over the care of any individuals. Navya’s products, services, systems, projects, or programs will not involve any direct face-to-face encounters or physical examinations. Accordingly, individuals using Navya’s products, services, systems, projects, or programs are encouraged to share and discuss any information provided as a result of use of Navya’s products, services, systems, projects, or programs with their treating physician. The individuals or patients using Navya’s products, services, systems, projects, or programs will be the ultimate decision maker over their own care.
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INDIVIDUALS OR PATIENTS USING NAVYA’S PRODUCTS, SERVICES, SYSTEMS, PROJECTS, OR PROGRAMS SHOULD NEVER DELAY OR AVOID SEEKING MEDICAL ADVICE OR ATTENTION FROM THEIR REGULAR HEALTH CARE PROVIDER OR TREATING PHYSICIAN OR DOCTOR BECAUSE OF SOMETHING THEY HAVE LEARNED THROUGH THEIR USE OF NAVYA’S PRODUCTS, SERVICES, SYSTEMS, PROJECTS, OR PROGRAMS. SHOULD ANY UNEXPECTED MEDICAL EVENT OCCUR WHILE AN INDIVIDUAL OR A PATIENT IS PARTICIPATING IN THE USE OF NAVYA’S PRODUCTS, SERVICES, SYSTEMS, PROJECTS, OR PROGRAMS, THE INDIVIDUAL OR THE PATIENT SHOULD IMMEDIATELY CALL THEIR HEALTHCARE PROVIDER OR TREATING PHYSICIAN OR DOCTOR OR LOCAL EMERGENCY ASSISTANCE NUMBER OR IMMEDIATELY VISIT THEIR LOCAL EMERGENCY ROOM. NAVYA AND ITS EMPLOYEES, CONSULTANTS, PARTNERS, AND EXPERTS ARE NOT AND SHALL NOT BE CONSTRUED AS BEING YOUR DOCTORS OR PHYSICIANS OR ONCOLOGISTS OR HEALTHCARE PROVIDERS FOR ANY PURPOSE WHATSOEVER.
This TMC NCG Online Expert Opinion Service, and Navya Network Inc., does not diagnose, treat, give orders, or have the ultimate authority over the care of any individuals. Page 9