Clinical Data on Recent Work with

Lu-177 EDTMP:
A Member State Experience

Tapas Das
Radiopharmaceuticals Division
Bhabha Atomic Research Centre
Trombay, Mumbai - 400 085, INDIA
tdas@barc.gov.in
 Eligibility Criteria
Patient Inclusion Criteria

 Histologically proven carcinoma

 Diagnosed with disseminated skeletal metastases through 99mTc-MDP whole-body scans

 Consistent bone pain

 Insufficient response or intolerance to opioid analgesics

 Adequate bone marrow function

 Performance status based on the Karnofsky score 40 and above

 Estimated life expectancy had to be at least 3 months

 Eligibility Criteria
Patient Exclusion Criteria
 Haemoglobin level less than 9 g%
 Total white cell count less than 3,500/mm3
 Platelet count less than 100,000/mm3
 Chemotherapy or radiotherapy within 4 weeks before administration of 177Lu-EDTMP
 Acute or chronic spinal cord compression, neurogenic pain, pathologic fractures
 Age younger than 18 years
 Pregnancy
 Breastfeeding
 Patients requiring surgery
 Preparation of Ready-to-Use 177Lu-EDTMP complex
for Human Administration

EDTMP 0.5 M NaHCO3 Saline

177LuCl
3
(35 mg) solution (pH 9) (0.9 mL) (0.1 mL)
(1 mL) 70-100 mCi

Incubation for 15 min pH = 7

at room temperature

Passed through Millipore filter

177Lu-EDTMP for human administration

70-100 mCi (2.59-3.7 GBq) activity
 Preparation 177Lu-EDTMP Patient Dose Using
Freeze-dried EDTMP kits

EDTMP cold kit

35 mg EDTMP 177LuCl
Normal Saline (1 mL) 3(Lu-2)
5.8 mg CaCO3
(70-100 mCi)
14.1 mg NaOH

Incubation for 15 min at RT

Passed through Millipore filter paper

177Lu-EDTMP for human administration

70-100 mCi (2.59-3.7 GBq) activity
 Whole-body Scans

99mTc-MDP bone scans (A) and corresponding

177Lu-EDTMP scans (B) showing excellent 99mTc-MDP bone scans (A) and corresponding
tracer localization in osteoblastic areas 177Lu-EDTMP scans (B) of the same patient
 Whole-body Scans

99mTc-MDP bone scans (A) and corresponding Whole-body scans recorded with (A) 153Sm-EDTMP and (B) 177Lu-
177Lu-EDTMP scans (B) showing excellent EDTMP in same patient demonstrating similar biological distribution
tracer localization in osteoblastic areas
Typical Analgesic Score & Karnofsky Performance Status Scale
 Efficacy of 177Lu-EDTMP as MBPP Agent
Initial Experiences

Pain score of patients treated with

100 mCi of 177Lu-EDTMP
From initiation of therapy to 12
weeks post-therapy Mean pain score of the study group
[10 patients & each patient treated with
100 mCi of 177Lu-EDTMP ]
 Efficacy of 177Lu-EDTMP as MBPP Agent
Initial Experiences

Toxicity data for 177Lu-EDTMP

[10 patients and each patient treated
Mean Karnofsky performance of the with 100 mCi 177Lu-EDTMP]
study group 4 weeks post-therapy
[10 patients and each patient treated
with 100 mCi 177Lu-EDTMP]
 Efficacy of 177Lu-EDTMP as MBPP Agent
Initial Experiences

Significant decrease of bone pain % Decreases in VAS over 16 weeks post-

reported in VAS for 32 prostate and 12 therapy. The maximum percentage
breast cancer patients decrease is seen at 4 weeks post-therapy
 Efficacy of 177Lu-EDTMP as MBPP Agent
Initial Experiences

Responses to pain palliation therapy Reduction of pain depicted in VAS

Low-dose (Group A) & From the time of treatment to 16 weeks
High-dose (Group B) treatment post-therapy

The response rates in both the groups

are similar
 Efficacy of 177Lu-EDTMP as MBPP Agent
Initial Experiences

Progress Chart of 177Lu-EDTMP Therapy

(Data obtained from 12 male patients suffering from
metastatic bone pain due to prostate carcinoma)
Efficacy of 177Lu-EDTMP as MBPP Agent
Documented by Other Member States

Clinical Nuclear Medicine, 38, 2013, 88-92

Efficacy of 177Lu-EDTMP as MBPP Agent
Documented by Other Member States

Clinical Nuclear Medicine, 38, 2013, 88-92

 177Lu-EDTMP Vs. 153Sm-EDTMP as MBPP Agents

Comparative VAS Score Comparative Karnofsky Performance

177Lu-EDTMP Vs. 153Sm-EDTMP 177Lu-EDTMP Vs. 153Sm-EDTMP
 Conclusion
Limited number of studies are reported and limited clinical data are available till date. However, the
few clinical studies reported till date indicate

 Systemic administration of 177Lu-EDTMP is an effective, well-tolerated and safe treatment option

for palliation of metastatic bone pain in patients with disseminated skeletal metastases

 Best results are seen 4 weeks post-therapy

 Efficacy in controlling the bone pain and toxicity exhibited by 177Lu-EDTMP are comparable with
153Sm-EDTMP

 Mild hematological toxicity and absence of renal toxicity indicate the high potential of 177Lu-EDTMP
as a palliative care radiopharmaceuticals

 More clinical studies in different population are warranted

 Acknowledgements

 International Atomic Energy Agency (IAEA), Vienna, Austria

 Prof. C.S. Bal and his colleagues, All India Institute of Medical Sciences (AIIMS), New Delhi
 Dr. Ajit Shinto and his colleagues, Kovai Medical Center and Hospital (KMCH), Coimbatore
 Dr. Sandip Basu and his colleagues, Radiation Medicine Centre (RMC), Bhabha Atomic Research
Centre (BARC), Mumbai
 My colleagues from Radiopharmaceuticals Division, Bhabha Atomic Research Centre (BARC), Mumbai
 My colleagues Board of Radiation and Isotope Technology (BRIT), Navi Mumbai, Mumbai
THANK YOU