LE SINDROMI DOLOROSE REFRATTARIE DA SECONDARISMI OSSEI E LA SCRAMBLER THERAPY

Transcription

1 LE SINDROMI DOLOROSE REFRATTARIE DA SECONDARISMI OSSEI E LA SCRAMBLER THERAPY K. Bencardino Niguarda Cancer Center Ospedale Niguarda Ca Granda, Milano 13 Marzo 2015

2 SCRAMBLER THERAPY It consists on positioning electrodes bilaterally outside the pain area to the proximal and distant area and works converting a pain information in non-pain information via electrical stimulation to the central nerve system The intensity of the electrodes is set to the maximum value at which the patient doesn t feel discomfort Frequency: 43 to 52 Hz 10 daily sessions of minutes We investigated its efficacy in control of cancer pain that failed the previous standard treatments, including medical therapy and locoregional tratment, such as radiotherapy The efficacy was evaluated with pain numerical rating scale (NRS)

3 BACKGROUND 2015 Clin J Pain 2014 Predictive Factors Associated with Success and Failure for Calmare (Scrambler) Therapy: A Multi-Center Analysis Moon JY, Kurihara C, Beckles JP, Williams KE, Williams KE, Jamison DE, Cohen SP

4 BACKGROUND

5 SCRAMBLER THERAPY FOR PHERIPHERAL NEUROPATHIES

6 PATIENTS CHARACTERISTICS Tot number of treated pts: 35, 25 with cancer Median age 61y (32-85y) Male/Female: 15 (60%)/10 (40%) Pts with solid tumors: 22 (5 lung cancers, 5 colorectal cancers, 5 pancreatic cancers, 1 sarcoma, 3 urothelial carcinomas, 1 pharyngeal cancer, 1 prostatic cancer, 1 breast cancer) Pts with hematologic malignancies: 3 (2 mieloma, 1 NHL) Pts with bone metastases: 17 (68%) (14 from solid tumors, 3 from hematologic malignancies) Pts with visceral metastases or primitive tumors: 5 (1 parapharingeal mass, 1 lung mass, 3 pancreatic cancer)

7 PATIENTS CHARACTERISTICS Table 1. Patients characteristics. ID Age(Years) Tumor Metastatic site RT benefit* 1 68 Lung cancer Bone (thighbone) no 2 32 Rectal cancer Bone (thighbone) yes 3 39 Colon cancer Bone (sacral vertebra) no 4 67 Abdominal sarcoma Bone (dorsal vertebra) no 5 64 Colon cancer Bone (left ribs) no 6 69 Lung cancer Bone (sacrum) no 7 66 pancreatic cancer Bone (sacrum) ND 8 67 Urotelial Carcinoma Bone (sacrum) yes 9 72 Urotelial Carcinoma Bone (pelvis) no Non Hodgkin Linfoma Bone (sacrum-iliac) no Mieloma Bone (vetrebrae) ND Mieloma Bone (thighbone) no Breast cancer Bone (lombar vertebra, sacrum)yes yes Prostatic cancer Bone (thighbone, rib) ND Lung cancer Bone (dorsal, lombar vertebra) ND Urotelial Carcinoma Bone (sacrum, iliac wing) no Lung cancer Bone (lombar vertebra) no Pancreatic cancer Frenic involvement by liver metastasis yes Pancreatic cancer Tumor no Colon cancer Frenic involvement by liver metastasis ND Lung cancer Lung mass no Pancreatic cancer Tumor no Colon cancer Pelvis (psoas) no Pancreatic cancer Tumor ND Head and Neck cancer Parapharyngeal mass no RT: radiotherapy * Yes: Pain reduction after RT, No: absence of pain relief after RT, ND: RT not done

8 RESULTS All patients responded to scrambler therapy (100%) The mean pain score reduced from 8,4 before treatment to 2,9 after treatment. No adverse events were reported and therapy was non-invasive and safe. The response duration ranged from 4 to 24 weeks, and reason for discontinuation of follow-up was patient's compliance (6 pts lost to follow up) and the short life expectancy (8 pts who gain pain control but died from cancer progression). Two pts repeated the treatment after 12 and 24 weeks respectively, obtaining a clinical benefit once again.

9 RESULTS We observed an opioids use reduction (meaning reduction in need of rescue therapy or/and decrease of daily opioid intake) in 19 pts (76%), with a consequent limitation of their side effects. 17 pts were affected by bone metastatic disease leading to chronic pain refractory also to radiotherapy. This group of patient benefit from scrambler therapy with a early reduction of pain after the beginning of treatment.

10 G.R Case Report (G.R.) April 2005: Surgery (RAR) for rectal adenocarcinoma pt3n2g2m0. KRAS mutation G12D. May-July 2005: adjuvant chemoradiotherapy (c.i. 5-FU + RT). July-December 2005: 6 courses of adjuvant chemotherapy with FOLFOX. Negative follow up until July 2007: anastomotical relapse. Surgery (Miles rectal amputation and colostomy). July 2007-January 2008: adjuvant CT with oral capecitabine. Negative follow up until March 2010: paravaginal and lung metastases. April-September 2010: 12 courses of CT with FOLFIRI + bevacizumab with PR. October 2010-April 2011: 9 courses of maintenance therapy with capecitabine and bevacizumab. May 2011: CT-scan: lung PD. 2 courses of FOLFOX, stopped for allergic reaction to oxaliplatin. July-September 2011: 3 courses with Dacarbazine in DETECT trial. CT-scan: PD. October 2011-March 2012: 9 courses of CT with FOLFIRI with SD. In december 2011 Radiotherapy on left lung lesion (39 Gy + boost 7 Gy). May 2012-October 2013: CT-scan (May 2012): lung PD. Therapy with Ragorafenib in Consign trial with PR and SD. October 2012: pain on left inferior leg. MRI: metastasis of superior third of left thighbone. Radiotherapy on left thighbone (20 Gy in 5 fractions). Zometa. CT-scan (October 2013): PD. In september 2013 RT on paravaginal mass with benefit. October 2013-January 2014: 6 courses of CT with FUFA De Gramont. CT-scan (January 2014): PD. January-July 2014: 9 courses of CT with FOLFOX with SD/initial PD.

11 Case Report (G.R.): MRI and CT-SCAN

12 Case Report (G.R.) October 2012: pain on left inferior leg treated with opioids, fans and neuroleptic drugs (matrifen, oxycontin, abstral, depalgos, actiq, toradol, rivotril, lyrica) with poor benefit. MRI: metastasis of superior third of left thighbone. Radiotherapy on left thighbone (20 Gy in 5 fractions) with response. After 3 months from the end of RT pain recurrence. April 2013-February 2014: many modifications of analgesic drugs and locoregional injections with lidocaine and steroids for intense pain on inferior left leg. In May 2013 hospitalization for bowel obstruction due to constipation from opioids. February 2014: Scrambler therapy on left inferior leg (9 sessions) with immediate benefit (NRS 10 0). Improvement in quality of life (she was able to work standing for several hours). August 2014: pain recurrence on left inferior leg. Scrambler therapy on left inferior leg (10 sessions) with immediate benefit (NRS 10 0). November 2014: brain metastases. Rt and best supportive care. December 2014: death.

13 CONCLUSIONS Non-invasive and safe technique No side effects High and fast responses Repeatable technique Useful choice in case of antalgic RT failure Reduction of opioids use and relative side effects Quality of life improvement Limited duration of response due to advanced diseases Treatment can be associated with medical oncologic therapy (chemotherapy) Treatment can be performed both in ambulatory and during hospitalization

14 FUTURE DIRECTIONS Use of scrambler therapy in pts selected for site of disease (i.e. bone metastases, primitive pancreatic cancer) with a prospective trial Use of scrambler therapy in pts with higher life expectancy in order to detect the real duration of response Quality of life detection