Risks of Adverse Events in Breast Cancer Patients Treated with Adjuvant Chemotherapy for the National Cancer Institute (NCI), Division of Cancer Control and Population Sciences (DCCPS)

Notice Number: SS-N02PC46010-71 Issued By: National Cancer Institute (NCI), Office of Acquisitions (OA) http://www.nci.nih.gov or http://rcb.cancer.gov/rcb-internet/ Key Dates: Capability Statement Due Date: January 15, 2014 by 4:00 PM EST This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The purpose of this Sources Sought Notice is to identify qualified small business concerns including 8(a), HUBZone or Service-Disabled Veteran-owned business concerns that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned North American Industry Classification System (NAICS) code 541990 with a size standard of $14 million is being considered As a result of this Sources Sought Notice, the NCI may issue a Request for Quotation (RFQ) through FedBizOpps. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Sources Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Breast cancer mortality rates have declined over the past 20 years and although much of the improvements in mortality have been attributed to early diagnosis and adjuvant treatment of early stage breast cancer, these treatment regimens are associated with substantial short-term toxicity and risk of long-term adverse effects, such as secondary malignancies, neuropathy, cognitive impairment, and cardiotoxicity. Until recently, women with breast cancer have received adjuvant chemotherapy based on clinical recurrence risk classification using qualitative tumor characteristics, such as size, type and grade, receptor status, and histology, although increasingly gene expression profiling is being used to direct adjuvant therapy choices. Nevertheless, many women will still receive adjuvant chemotherapy that will have only a modest effect on disease-free and overall survival. These patients may receive limited benefit from chemotherapy and an improved understanding of these long-term adverse risks of treatment could help to inform clinical decision-making about adjuvant chemotherapy (i.e., women with low risk of recurrence could avoid potential toxicity and morbidity of adjuvant chemotherapy). Even when use of chemotherapy is indicated, patients are seldom informed about the specific risks for long-term and late effects, which could potentially inform treatment decision-making. Yet, no systematic reviews or risk appraisal have addressed this question. Long-term and late adverse effects (e.g., leukemia, congestive heart failure, neuropathy, cognitive dysfunction, infertility) of chemotherapy are widely acknowledged, but their risks are not explicitly considered in currently available risk prediction models. This limits the ability of clinicians and patients to weigh the potential harms versus benefits of adjuvant chemotherapy in treatment decision making. Randomized trials of adjuvant chemotherapy have predominantly focused on evaluating the reduction in cancer recurrence and on treatment-associated short-term adverse effects. Less attention has been given to long-term adverse effects of these cytotoxic drugs, which may have significant negative impacts on health and QOL for breast cancer survivors long after their treatment ends. The aim of this requirement is to estimate the rates of long-term adverse effects of commonly used adjuvant chemotherapy regimens for breast cancer by conducting a systematic review of the literature and by analyzing data collected from a clinical trial of over 5,000 patients with node-positive breast cancer. This project is critical not only to define what the NCI currently knows about treatment harms, but perhaps more importantly, to identify gaps in existing knowledge that will guide future research. This project will help inform the NCI in the planning and prioritizing future research initiatives developing patient-level risk prediction model to assist patients and clinicians in making informed decisions about the benefits and risks of adjuvant chemotherapy for early stage breast cancer. Contractor Requirements: The Contractor shall provide adequate equipment, supplies, facilities, and scientific materials necessary for carrying out the requirements of this project. The Contractor shall work on several key tasks, including but not limited to the following: 1. Evaluate the literature on long-term adverse events following treatment with adjuvant chemotherapy in breast cancer patients draft a manuscript reporting the findings. a. Specifically, information from published literature on chemotherapy agents commonly used in the U.S. for breast cancer adjuvant therapy (i.e., anthracyclines, cyclophosphamide, taxanes, and trastuzumab) and the risk of chemotherapy-related adverse events (i.e., cardiac toxicity, ovarian failure, secondary malignancies, neurotoxicity, and cognitive dysfunction) will be systematically reviewed and described. The completed manuscript shall be submitted to a peer-reviewed journal. (Task 1) 2. Conduct secondary analyses using data from the NSABP B-30 trial to estimate the frequency and impact of adverse events resulting from adjuvant chemotherapy and draft a manuscript reporting the findings. a. Data from the NSABP B-30 trial, which enrolled over 5,000 node-positive breast cancer patients who were randomized to three different treatment arms containing an anthracycline and a taxane, shall be analyzed by the Contractor and shall supplement finding from the systematic review (Task 2). Government Responsibilities: The Contracting Officers Representative (COR) will review draft deliverables and provide the contractor with timely comments. Reporting Requirements and Deliverables: The Contractor's work products shall be subject to the review and approval of the COR. Any deficiencies identified must be corrected prior to final approval. The COR will complete review of the work within 1 month. If no comments or request for revisions are provided to the Contractor within 1 month, the deliverables will be considered acceptable. Payment shall be made after acceptance by the Government of each deliverable. Period of performance: 12 months from the date of award. How to Submit a Response: 1. Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed 10 single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the ability to perform the requirements of the notice described above. All proprietary information should be marked as such. Responses should include a minimum of a two pages demonstrating experience over the past two years meeting the requirements of this notice. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferable placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. 2. Due Date: Capability statements are due no later than 4:00 PM EST on January 15, 2014. 3. Delivery Point: All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. Written responses can be emailed to Huy Nguyen, Contract Specialist at anh-huy.nguyen@nih.gov or mailed to the address located under Point of Contact. All questions must be in writing and can be faxed to (240) 276-5401 or emailed. A determination by the Government not to compete this requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference number SS-N02PC46010-71 on all correspondence. 4. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, an RFQ may be published on FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation(s). Point of Contact: Inquiries concerning this Notice may be direct to: Huy Nguyen 9609 Medical Center Dr, Room 1E144 Bethesda, MD 20892-9705 anh-huy.nguyen@nih.gov