Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 51-year-old woman who was diagnosed with left breast cancer in December 2003. At that time she was found to have a 1.3cm invasive ductal carcinoma with two positive nodes, one of which apparently was palpable to the surgeon. She has been treated with adjuvant chemotherapy including Adriamycin, Cytoxan, and Taxotere. Since her surgery was a segmental mastectomy, she now requires radiation therapy to the breast.The patient has been seen by radiation therapy who discussed the technique of whole breast radiation, including possible toxicities. It has been proposed the patient receive radiation only to the area of the tumor, using intensity-modulated radiation therapy (IMRT).It is standard and advisable for women who undergo less than a mastectomy to undergo radiation therapy to the breast. Radiation has been shown to significantly decrease cancer recurrence in the treated breast. Conventionally, this has been accomplished by radiating the whole breast, which does expose the patient to a slight risk of toxicity to the heart and/or lungs, though such toxicity is almost never of clinical significance.In the past few years there has been much interest in techniques wherein only the area adjacent to the site of the cancer is treated. This interest was generated by the observation that the majority of recurrences that do occur within the breast occur quite close to the site of the original cancer. There are many techniques being used and studied including mammosite (the insertion of a balloon with radiation-containing beads) and brachytherapy (implant radiation with needles). Some protocols using these therapies require the patient to be node-negative, which is not true of this patient. Though the early data from these studies does look promising, longer-term data is needed to be able to compare their results with those of more standard whole breast radiation. There has also been a concern that such techniques may produce unacceptable local toxicities when the patient has also been given chemotherapy, as has this patient.IMRT is a newer form of very localized and precise radiation. It certainly has its uses where such precision is critical to avoid toxicity to adjacent tissues, e.g., when radiating the prostate gland for cancer. However, its use in this situation is truly at its earliest stages. Because of the various unknowns concerning interaction with chemotherapy, and overall short and long-term results, the efficacy of IMRT in this clinical setting remains unproven.Based upon the information set forth above, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2The patient is a 51-year-old female who has infiltrating duct cell carcinoma. The tumor size is 1.3cm maximal with clear margins based on the resection, which was free of cancer cells. The submitted records indicate 2 of 13 lymph nodes contained metastases. Both ER and PR were positive. She underwent segmental mastectomy and lymph node dissection followed by conventional chemotherapy with four cycles of Adriamycin and Cytoxan followed by Taxotere. The patient received her last dose in June 2004. She is ready to start her indicated post-operative and post-chemotherapy radiation therapy. The patient wishes to receive intensity-modulated radiation therapy (IMRT). The Health Plan has denied the patients request on the basis that IMRT is considered investigational for treatment of breast cancer.External beam radiation (XBRT) has been well studied by the National Surgical Adjuvant Breast (NSAB) group. The efficacy of the dose, side effects, and complications associated with XBRT have been established.  XRBT is the gold standard against which all new modalities of radiation should be compared. The prescribed dose is 5000 cGy in 25 fractions over 5 weeks, which is standard for all radiation oncologists in the U.S.Because the resection had no malignant cells in the specimen it is unnecessary for the patient to receive a boost to the tumor bed. She does not need any elective axillary irradiation. With XRBT the patients side effects will be limited to mild lethargy and mild skin reaction. Later complications include a small risk of rib fracture always self-limiting and asymptomatic radiation pneumonitis. Over the past few years, partial breast irradiation such as IMRT has been investigated to minimize further the side effects and reduce the time necessary for XBRT. IMRT is based on computerized external radiation. It offers the benefit of XBRT without the invasiveness of the other partial breast irradiation modalities. However, IMRT is under phase I/II investigation. Its dose levels and toxicities are still being investigated and it is not ready for general public use. Conventional XBRT remains the gold standard.  Based upon the information set forth above, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3This patient is a 51-year-old female who discovered a lump in the upper outer quadrant of her left breast. An ultrasound showed a mass in her left breast. Excisional biopsy showed primary infiltrating ductal carcinoma. The patient then underwent left segmented mastectomy and axillary mode dissection. The patient received chemotherapy and a radiation oncology consultation. She now wishes to undergo partial breast irradiation using intensity-modulated radiation therapy (IMRT). The Health Plan has denied authorization and coverage for IMRT on the basis it is considered experimental.This patient with early stage breast cancer wishes to undergo partial breast irradiation using IMRT. The proposed treatment is well designed with decreased treatment time. IMRT decreases hot spots and improves dose homogeneity compared to interstitial implant. Furthermore, IMRT is more precise and accurate than boost treatment. Many radiation oncology centers have started using IMRT for treatment of the entire breast and then boost treatment. Partial breast irradiation using IMRT reduces the volume of breast that receives high-dose radiation and the planning by computer provides good coverage of target volume. Therefore, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.