FDA Expands Indication for Scalp Cooling System to Include All Solid Tumors


The FDA has expanded the indication for the Orbis Paxman Hair Loss Cooling System to prevent chemotherapy-related alopecia in patients with solid tumors.

The FDA has expanded the indication for the Orbis Paxman Hair Loss Cooling System to prevent chemotherapy-related alopecia in patients with solid tumors, device maker Paxman has announced. The system was approved last year to treat chemotherapy-related alopecia in patients with breast cancer.

In a statement, the company said the expanded approval will increase the number of newly diagnosed patients who can use the system from roughly 250,000 per year to more than 1 million.

“Scalp cooling has been a real game changer for so many of our patients with breast cancer, minimizing the risk of one of the most dreaded side effects of chemotherapy,” Steven J. Isakoff, MD, PhD, a clinical and translational investigator in the breast oncology center at Massachusetts General Hospital, said in a press release. “We are already working on plans to make this available to all of our patients with solid tumors.”

The FDA approved the Orbis system for women with breast cancer in April 2017 based on results from the SCALP trial (NCT01986140) first presented at the 2017 ASCO Annual Meeting and subsequently published in the Journal of the American Medical Association.1,2 In SCALP, investigators assessed hair preservation in 95 women assigned to scalp cooling versus a control group of 47 women who did not receive scalp cooling.

Secondary endpoints included change in quality of life and use of wigs or head wraps.

The trial was stopped early following a preplanned efficacy analysis of 142 participants. Investigators will follow participants for 5 years poststudy to assess time to first recurrence, site of first recurrence, and overall survival.

Eligible patients with stage I-II breast cancer were treated with neoadjuvant or adjuvant anthracyclines or taxanes for a minimum of 4 cycles. Patients suffering from migraines, hypothyroidism, or anemia were excluded, as were patients with any other uncontrolled medical condition.

The mean patient age was 50.8 years and 79.9% of the cohort was white. Sixty-three percent of patients were treated with taxanes while 37% received anthracycline-based treatment. Most women (62.5%) had stage II disease, while 37.5% had stage I tumors.

After 4 cycles of treatment, the rate of hair preservation was 53.1% in the experimental group compared with 0% in the control group (P <.0001). Following completion of chemotherapy (4-8 cycles), the rate of hair retention in the cooling arm was 46.2%.

Women assigned to a taxane were more likely to preserve their hair after 4 cycles (63% vs 24.1%) and after completion (64.6% vs 0%). The rate of hair preservation after completion of treatment for patients who received both classes of drugs was 15.6%.

The rate of hair preservation was 100% for patients assigned to paclitaxel alone (n = 7) or in combination with 6 AUC of carboplatin (n = 1).

“This is another step forward in making cancer therapy more personalized and putting the patients in the driver’s seat as we create more options and pathways our patients,” Debu Tripathy, MD, professor and chair of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center, said in a statement.

There was no difference in quality of life scores between the experimental and control arms, or between those who had alopecia and those retained their hair.

All adverse events associated with the cooling system were grade 1/2. Following 4 cycles of chemotherapy, 4.8% of patients experienced headache and 1.2% experienced nausea.

At this year’s ASCO meeting, investigators presented results from a retrospective analysis of the efficacy and safety of the Paxman system.3 Data from 86 women with primary breast cancer who received neoadjuvant or adjuvant treatment with anthracyclines, taxanes, or both were included in the findings.

All patients received sensor-controlled scalp-cooling (SCSC) treatment during chemotherapy. Investigators assessed chemotherapy-induced alopecia 3 weeks after chemotherapy completion. A quality of hair preservation score of 0 to 2 was considered a success; 3 to 4 was considered a failure.

The success rate for hair preservation was 64%. Thirty-five (40.7%) patients had complete preservation and 20 (23.3%) had partial preservation.

The efficacy of scalp cooling was similar in pre- and postmenopausal women, and for adjuvant and neoadjuvant treatment. However, the success rate for patients assigned to a taxane (80.0%) or a taxane followed by an anthracycline (73.9%) was significantly greater than for those who received an anthracycline followed by a taxane (47.4%; P = .016).

Twenty-seven (31.4%) patients discontinued scalp cooling, with most (24.4%) citing alopecia as the reason. Six patients complained of local discomfort (n = 3; 3.5%) or pain (n = 3; 3.5%).

The Orbis system is the second scalp cooling system granted FDA approval. The agency approved the DigniCap System for patients with breast cancer in December 2015. That indication was expanded to include all solid tumors in 2017.


  1. Nangia JR, Wang T, Osborne CRC, et al. Scalp Cooling Alopecia Prevention trial (SCALP) for patients with early stage breast cancer. J Clin Oncol. 35, 2017 (suppl; abstr 10088).
  2. Nangia JR, Wang T, Osborne CRC, et al. Effect of a scalp cooling device on alopecia in women undergoing chemotherapy for breast cancer: the SCALP randomized clinical trial. JAMA. 2017;317(6):596-605. doi:10.1001/jama.2016.20939.
  3. Kurbacher CM, Herz S, Kurbacher AT, et al. Sensor-controlled scalp cooling for chemotherapy-induced alopecia: Safety and effectiveness in primary breast cancer patients exposed to anthracyclines and/or taxanes in the neoadjuvant or adjuvant setting. J Clin Oncol. 36, 2018 (suppl; abstr e22196).

In the cooling arm, 44.6% of patients used a wig or scarf compared with 68.5% in the control group. Among patients with grade 2 (>50%) hair loss, wig or scarf use was unknown for 20% of patients in the experimental arm versus 31.5% of the control group. No woman in the control group was known to go without a scarf or wig compared with 33.9% of the cooling group.

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Adam S. Faye, MD