LANDONI Study
Randomized study of radical surgery versus radiotherapy for stage Ib-IIa cervical cancer
Disease site
Cervix
Pubmed link
Publication month/year
August 1997
Study question
To compare the efficacy of radial surgery with pelvic radiation for the treatment of newly diagnosed stage Ib -IIa cervical cancer
Type of study
Randomised controlled trial (RCT)
Interventions compared
Radical surgery vs pelvic radiation
Experimental arm (Intervention)
Class III radical abdominal hysterectomy with pelvic lymph node dissection
*Adjuvant radiotherapy was given if: *
- Surgical stage > pT2a
- Lymph node metastasis
- <3 mm of disease- free cervical stroma
Control arm
External pelvic irradiation using 18 MV photon beam
Primary outcome
- 5-year survival
- Rate of complications
Secondary outcome
- Recurrence
Inclusion criteria
- Age 30-70 years
- Newly diagnosed cases of cervical cancer
- FIGO stage Ib – IIa
- WHO performance status of 1 or less
Exclusion criteria
Concurrent or history of malignancy
Results
| Intervention arm | Control arm | |
|---|---|---|
|
Randomised (n) |
169 |
158 |
|
Received treatment |
Radical surgery and pelvic lymph node dissection |
Radiotherapy |
|
Overall 5-year survival |
80%
|
82% |
|
5-year survival if cervical diameter ≤4 |
87% |
90% |
|
5-year survival if cervical diameter >4 |
70% |
72% |
|
Recurrence rate (%) |
25% |
26% |
Other Results
Complications in intervention arm :
- Severe (grade 2-3): 48 (28%)
- Hydroureteronephrosis: 2 (3%)
- Chronic neurological bladder: 8 (13%)
- Severe lower limb edema: none
Complications in Control arm:
- Severe (grade 2-3): 19 (12%)
- Hydroureteronephrosis: 8 (5%)
- Chronic neurological bladder
- Severe lower limb edema: 1 (0.6%)
Complications in patients receiving surgery plus radiotherapy:
- Hydroureteronephrosis: 11 (10%)
- Chronic neurological bladder 5 (5%)
- Severe lower limb edema: 10 (9%)
(11) patients died due to cervical cancer
(2) patients died of complications: bowel perforation and pulmonary embolism (Both deaths occurred in the surgery group)
Conclusions
The study yielded no significant difference in the efficacy of either treatment modality. Thus, optimal therapy should take into consideration the clinical status of each individual. Moreover, the combination of radiotherapy and surgery resulted in the highest number of complications.
Study limitations
The data showed a discrepancy in the efficacy of radiotherapy in comparison with surgery for adenocarcinoma of the cervix, thus, histological types should be taken into consideration during the sample selection.