Robotics in Head and Neck Cancer: Future Opportunities

October 15, 2010

A series of promising new advances have emerged in H&N oncology in recent years. Among these are the advancement of highly conformal radiation delivery techniques (e.g. IMRT, protons); the successful introduction of molecular targeted therapies (e.g. cetuximab); the recognition of HPV as a powerful prognostic biomarker; and the development of minimally invasive surgical techniques. The application of transoral robotic surgery (TORS) in H&N cancer is reviewed by Bhayani et al in this issue of ONCOLOGY[1].

Promising Head & Neck Oncology Advances

A series of promising new advances have emerged in H&N oncology in recent years. Among these are the advancement of highly conformal radiation delivery techniques (e.g. IMRT, protons); the successful introduction of molecular targeted therapies (e.g. cetuximab); the recognition of HPV as a powerful prognostic biomarker; and the development of minimally invasive surgical techniques. The application of transoral robotic surgery (TORS) in H&N cancer is reviewed by Bhayani et al in this issue of ONCOLOGY[1].

Robot-assisted surgery has undergone further development in the disciplines of gynecology, urology, general and cardiothoracic surgery, and is a relative newcomer in H&N oncology. Bhayani summarizes the potential advantages of TORS including less collateral tissue damage (e.g. swallow and airway function), improved surgical dexterity, and shorter hospital stays, along with the potential disadvantages, which include significant expense for equipment, lack of tactile feedback during surgery, and a steep learning curve for surgeon and operating room personnel.

Many factors influence the advancement of new technologies in medicine. This commentary will consider several as they pertain to TORS in H&N cancer.

Provider Bias

There is a natural tendency for physicians to be most interested in developments that involve their own subspeciality. In the context of H&N cancer, the radiation oncologist with IMRT or protons may be eager to apply these complex tools for every H&N case, the medical oncologist eager to deliver induction chemotherapy, and the surgeon with transoral laser and robotics eager to test these in suitable patients. All of these techniques offer great potential value, yet they are complex and costly, and unlikely to provide global benefit unless judiciously applied to those specific patients most likely to derive benefit.

Data Interpretation

How many modalities are required to effect optimal outcome for H&N cancer patients? The promising report of 45 patients treated with TORS for oropharynx cancer by Moore et al[2] concludes that TORS “provides a new benchmark of function and complication rates with which other series of treatments for oropharyngeal cancer can be compared.” Isolating the impact of TORS in this setting is challenging, however, as the authors report that 73% of these patients went on to receive radiation with IMRT in the adjuvant setting. Over half of these patients also received systemic chemotherapy. Long-term reports confirm very high rates of locoregional control for oropharynx cancer with radiation or chemoradiation alone. Will TORS further enhance local control and/or enable de-intensification of non-surgical therapies? Or, will TORS simply add additional cost and competition? Who serves as patient guardian of the “optimal” approach that impartially considers outcome efficacy, quality of life, cost and patient preference?

Controlled Clinical Trials

Ideally, each new technique and technology would be studied systematically in the context of controlled clinical trials. These efforts would culminate in randomized phase III multicenter trials that rigorously compare outcome between experimental approach and standard of care. Physicians would not be linked in any way to industry sponsors of commercial products, nor would trials be designed, financially supported, or analyzed by industry representatives. If randomized trials confirmed unequivocal benefit, the approach would be advanced. If trials showed no compelling benefit, the approach would be abandoned. For a variety of reasons, this simplistic and idealistic approach to the adoption of new technologies is rarely employed.

Learning Curve and Provider Training

Unbeknownst to most consumers, possession of new technology is not synonymous with expertise in its application. For complex technical procedures, there is a learning curve. To become proficient in the effective delivery of H&N IMRT, for example, a radiation oncologist and physics team may require personal experience with more than 100 cases. This team experience appears similar for robot-assisted surgery. Most patients would prefer not to be treated within this learning curve for either H&N IMRT or TORS, and yet this is exactly where the majority of patients reside today. The competitive nature of US medical practice encourages practitioners to adopt new technologies regardless of the expertise providers are able to maintain. Ideally, centers of excellence would optimize patient outcomes. There is ample published data that shows that improved outcomes are achieved for complex cancer therapies when providers and centers carry high caseload experience.[3,4]

Nevertheless, the U.S. system generally favors decentralized health care delivery and it is therefore essential that physicians receive quality training in new techniques. Bhayani suggests that implementation of a standardized surgical training curriculum for TORS during residency and fellowship education is vital and we fully agree. It would be ideal to separate this training from the influence of industry sponsors. This separation has not always been effectively accomplished in medical and radiation oncology, where the financial influence of pharmaceutical and technology sponsors often link physicians and clinical trials to the promotion of new treatment approaches.

Technology and Health Care Costs

A 2010 summary perspective published in the N Engl J of Med analyzed health care costs in the broad arena of robot-assisted surgery.[5] Examining all cost studies of robot-assisted procedures published since 2005 across 20 types of surgery (none in H&N to date), the authors identify that robotic surgery appears to have increased the cost per surgical procedure and volume of cases treated surgically, but without clear evidence for long-term improvement in overall patient outcome or quality of life. Factors such as competitive advantage to offer new technologies and hospital pressures to utilize expensive instrumentation may contribute to this increased utilization.

Promoting Surgical Trials

There is a strong inverse relationship between the effectiveness of a therapeutic modality and the portfolio of clinical trials that investigate the topic. For example, chemotherapy alone might be expected to cure on the order of 0-10% of patients with H&N cancer, and yet the overwhelming majority of clinical trials over several decades involve the use of chemotherapy. In contrast, surgery alone is curative for many H&N cancer patients and yet the percent of clinical trials that isolate a surgical question are exceedingly small. Understandably, we desperately desire more effective systemic therapies. After all, cetuximab was the first new agent to receive FDA approval for H&N cancer in over 40 years. Nevertheless, the curative treatment modalities (surgery in particular) should not be neglected in the clinical trials setting. Small gains in H&N surgical oncology could prove very powerful in impacting overall cancer outcome. If one H&N surgeon is more likely than the next to establish clear resection margins, effect superior functional outcomes, and achieve a lesser complication profile, we would all do well to enable the training of more such H&N surgeons.

Conclusions

H&N oncology has a wonderful opportunity to investigate and advance TORS in a rigorous scientific fashion. Although TORS may be more of a promising new tool than a “shifting paradigm,” there is compelling evidence that it warrants systematic evaluation. Controlled clinical trials would be highly desirable in this setting, thereby enabling important questions to be answered in a manner that inspires high confidence in the results. This is an ideal time for all H&N oncologists to fully support H&N surgeons in the design of robust trials to study this promising new technology. With creativity and multidisciplinary teamwork, cooperative oncology groups and H&N SPORE grant programs may offer an ideal venue to advance this valuable mission.

Financial Disclosure:The authors have no significant financial interest or other relationship with the manufacturers of any products or providers of any service mentioned in this article.

References:

References

1. Bhayani MK, Holsinger FC, Lai SY. A shifting paradigm for patients with head and neck cancer: transoral robotic surgery (TORS). Oncology (current issue).

2. Moore EJ, Olsen KD, Kasperbauer JL. Transoral robotic surgery for oropharyngeal squamous cell carcinoma: a prospective study of feasibility and functional outcomes. Laryngoscope. 2009; 119:2156-64.

3. Schrag D, Panageas KS, Riedel E et al. Hospital and surgeon procedure volume as predictors of outcome following rectal cancer resection. Ann Surg. 2002; 236: 583-592.

4. Peters LJ, O’Sullivan B, Giralt J et al. Critical Impact of radiotherapy protocol compliance and quality in the treatment of advanced head and neck cancer: results from TROG 02.02. J Clin Oncol. 2010; 28: 2996-3001.

5. Barbash GI and Glied SA. New technology and health care costs: the case of robot-assisted surgery. N Engl J Med. 2010; 363: 701-04.