In Defense of A Status Quo Challenger
Updated: Nov 23, 2019
This letter to the editor was offered in response to a November 2019, Desert Sun article regarding a surgeon who was placed on probation by the California Medical Board related to offering cryoablation or “tumor freezing” to women seeking an alternative to surgery for early stage breast cancer.
As a breast cancer surgeon, researcher and patient advocate, I feel it necessary to challenge the negative impressions that the article creates regarding cryoablation, the surgeon and the growing number of women seeking alternatives to “traditional” surgical treatment.
Although cryoablation is new to most readers, the procedure has served a role in the management of cancer for decades. For example, cryoablation had long been used to treat pre-cancerous growths of the cervix and is now increasingly used for treatment of early stage prostate cancer. I have been performing breast cryoablation since 2003, initially as a treatment of benign breast tumors called fibroadenoma, and later beginning in 2009 for early stage breast cancer as part of a national clinical trial sponsored by the American College of Surgeons.
The American College of Surgeon’s 2009 trial found cryoablation to be 100% effective at killing invasive breast tumors that were 1 cm or smaller and 92% effective for tumors up to 2 cm. As a result of the lessons learned from that trial, two additional national trials were launched evaluating cryoablation as an alternative to surgery for early stage breast cancer. Currently, the early results of both trials are promising and I am honored to serve as lead principal investigator for one of them, the FROST Trial (https://clinicaltrials.gov/ct2/show/NCT01992250).
Internationally, the most promising breast cancer cryoablation experience comes from Japan, where a respected surgeon has treated more than 300 women with estrogen-sensitive breast cancers 1.5 cm or smaller with cryoablation, radiotherapy, and anti-estrogen therapy. This method has achieved a local control rate of 99% at 6 years average follow-up, and rivals what we can achieve with surgery. However, unlike surgery, cryoablation is a relatively pain-free procedure that can be performed through a 3 mm skin nick under local anesthesia as a 1 hour office procedure, with expedited return to normal activity and no long-term changes of breast shape or volume.
Based on growing international experience, I am certain that cryoablation will one-day become a standard option for U.S. women with early stage breast cancer and for some women with more advanced breast cancer. This view is supported by Medicare’s recent decision to establish a CPT (billing) code for breast cancer cryoablation and as well by the recent National Institute of Health suggestion to evaluate cryoablation as a treatment of Stage 0 breast cancer (ductal carcinoma in sit), an effort that I am currently undertaking. The challenge for breast surgeons and breast cancer researchers such as myself is to determine which patients and which breast cancer types are most appropriate for cryoablation.
The primary issue raised by the California Medical Board was “informed consent”. Informed consent is essential for everything we do as cancer specialists, whether it’s lumpectomy, mastectomy, radiation, chemotherapy, or other treatments. Each treatment can reduce cancer recurrence, but none is guaranteed to prevent recurrence. To varying degrees, each is also capable of causing physical or emotional harm that can impair short-term or long-term quality of life. The goal of informed consent is to ensure that patients are aware of these factors and possible alternatives so that they can determine which treatment regimen suits them best. As it turns out, compared to their doctors, patients tend to be more willing to accept risk and explore novel treatment options. However, as surgeon-innovators, we must also temper our enthusiasm to offer patients new treatment advancements by ensuring that they are fully informed about what is known and more importantly, unknown about the innovations we offer.
Criticism of the disciplined surgeon must also be judged in the context of a long history of surgeon-innovators and patient advocates who sought to make breast cancer surgery less disfiguring and less harmful to women. For example, if not for the advocacy and independent research efforts of Umberto Veronesi, an Italian surgeon, and Bernard Fisher, an American surgeon, women across the globe might still be subjected to radical mastectomy with removal of the entire breast, chest muscles and underarm lymph nodes. Radical mastectomy was the standard breast cancer operation for all stages of breast cancer as little as 40 years ago. Though criticized by the medical community-at-large and ostracized by surgical societies, the leadership provided by Drs. Veronesi and Fisher made it possible today for most women to be offered lumpectomy and radiotherapy instead of radical mastectomy. However, ultimate credit goes to the communities of women around the world who demanded different and better options for treating breast cancer. Today’s physicians are facing the same call-to-action. At the end of the day, most major advancements in cancer care are driven by physicians and patients seeking something better than the status quo.
Cryoablation is not the only place where the disciplined surgeon challenged the status quo. Readers might also be surprised to learn that he played a seminal, but similarly controversial role in establishing tamoxifen as a treatment option for breast cancer. His early advocacy for tamoxifen stimulated national research efforts that ultimately established tamoxifen and similar medications as the preferred anti-cancer medication for women with estrogen-sensitive breast cancer. The human impact of this innovation is immeasurable.
My first status quo challenge began in 2005 with my efforts to eliminate the side effects and burden of breast radiotherapy with the use of single-dose intraoperative radiotherapy (IORT), a procedure that reduced the usual 3- to 6-week course of radiation after lumpectomy to a brief 30-minute dose of radiation given during surgery immediately after lumpectomy. After facing years of criticism from the radiation oncology community but tremendous support from patients, the decade-long endeavor of myself, my colleagues and patients to make IORT a standard option for women has been vindicated by long-term data supporting its safety and effectiveness, increasing adoption by radiation oncologists, and coverage by Medicare and most health insurance plans. I now serve as President of the Targeted Intraoperative Radiotherapy Collaborative Group, a national organization of surgeons, radiation oncologists, and physicians committed to expanding access to IORT.
It is safe to say that most physicians are motivated by their sworn professional obligation to “first do no harm” and by the desire to achieve the best possible outcome for their patients. However, it is no longer acceptable for physicians to be the sole judge of what is best for individual patients and to impose their own value-system on their patients. The new standard is “patient-center care.” The Institute of Medicine defines patient-centered care as “providing care that is respectful of, and responsive to, individual patient preferences, needs and values, and ensuring that patient values guide all clinical decisions.” Thus, for patients wishing to avoid traditional surgery, radiotherapy, or chemotherapy, it is therefore the challenge and responsibility of physician-innovators and advocates to develop a range of treatment options that allow patients to select therapies appropriate for their tumor biology, tumor extent, physical anatomy, and willingness to tolerate risks and side effects. It is in this context that I support ongoing efforts to expand access to cryoablation including launching the following informational website: www.cryoablation.com.
In many ways, I feel that the reaction to cryoablation mirrors the early days of lumpectomy and IORT. However, I am confident that the next 10 years will see breast cryoablation emerge as an established option for women with breast cancer. For this to happen, we must continue to monitor the outcome of ongoing trials and develop new trials for early and later stage breast cancer. Patients must understand that breast cryoablation is not intended to be a substitute for all other cancer therapies. Much like lumpectomy and mastectomy, cryoablation works best when supplemented by radiotherapy and/or drug therapy, as appropriate. On the other hand, physicians must not hold cryoablation to a higher standard than we hold other cancer treatments. If a woman undergoes lumpectomy but later declined recommended radiation, we don’t deny all other women access to lumpectomy or insist that she return to the operating room for a mastectomy lest we fire her from our practice—at least most of us don’t. If a woman accepts tamoxifen but refuses chemotherapy despite its promise of additional survival benefit, we physicians still try to help her achieve the best possible outcome that can be achieved with tamoxifen alone. When the roles are reversed and the physician becomes the patient, we also expect our healthcare providers to respect our right of self-determination.
At the end of the day, our highest responsibility as physicians is to equip patients with the knowledge required to make informed decisions about a range of imperfect treatment options. This practice will empower them to make healthcare decisions that best suit their individual physical and emotional needs from both a survival and quality of life perspective.
Dennis R. Holmes, M.D., F.A.C.S.
Breast Cancer Surgeon and Researcher
Los Angeles, CA