Treatment History of Relapse APL Cases
Case No.-150 . | Induction . | Consolidation . | Maintenance . | Relapse . | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Rx Type . | Rx Result . | Days RA . | Cycles DA . | Cycles DA . | Proto Arm . | Days RA . | Days Post-CR . | Days Post-RA . | Days RA . | |
1 | DA | CR | 0 | 1 | 2 | Obs | 0 | 541 | — | 0 |
2 | DA | CR | 0 | 1 | 2 | Obs | 0 | 266 | — | 0 |
3 | DA | CR | 0 | 1 | 2 | Obs | 0 | 542 | — | 0 |
4 | DA | CR | 0 | 1 | 2 | Obs | 0 | 203 | — | 0 |
5 | DA | CR | 0 | 1 | 2 | Obs | 0 | 124 | — | 0 |
6 | (RA)DA-151 | CR | 0 | 1 | 2 | Obs | 0 | 488 | — | 0 |
7 | DA | CR | 0 | 1 | 1 | — | — | 119 | — | 0 |
8 | DA | CR | 0 | 2 | — | — | — | 47 | — | 0 |
9 | DA | CR | 0 | 1 | 2 | RA | 142 | 258 | 0 | 142 |
10 | DA | CR | 0 | 1 | 2 | RA | 365 | 566 | 90 | 365 |
11 | DA | CR | 0 | 1 | 2 | RA | 365 | 821 | 344 | 365 |
12 | DA-RA(OP) | 1°Res-CR-152 | 82 | 1 | 0 | RA(OP) | 99 | 128 | 30 | 181-153 |
13 | RA | CR | 42 | 0 | 2 | Obs | 0 | 334 | 334 | 42 |
14 | RA | CR | 52 | 0 | 2 | (RA)Obs-155 | 0 | 188 | 174 | 52 |
15 | RA-DA | 1°Res-CR¶ | 44 | 1 | 2 | Obs | 0 | 522 | 540 | 44 |
16 | RA-DA(OP) | Dc-CR# | 19 | 1 | 2 | — | 0 | 348 | 410 | 19 |
17 | RA | CR | 50 | 0 | 2 | RA | 365 | 563 | 49 | 415 |
18 | RA | CR | 73 | 0 | 2 | RA | 97 | 202 | 0 | 275 |
19 | RA | Tox/CR-160 | 23 | 0 | 0 | — | — | 192 | 189 | 23 |
20 | RA(OP)-164 | CR | 39 | 0 | 0 | RA(OP)-164 | 312 | 324 | 0 | 351-153 |
Case No.-150 . | Induction . | Consolidation . | Maintenance . | Relapse . | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Rx Type . | Rx Result . | Days RA . | Cycles DA . | Cycles DA . | Proto Arm . | Days RA . | Days Post-CR . | Days Post-RA . | Days RA . | |
1 | DA | CR | 0 | 1 | 2 | Obs | 0 | 541 | — | 0 |
2 | DA | CR | 0 | 1 | 2 | Obs | 0 | 266 | — | 0 |
3 | DA | CR | 0 | 1 | 2 | Obs | 0 | 542 | — | 0 |
4 | DA | CR | 0 | 1 | 2 | Obs | 0 | 203 | — | 0 |
5 | DA | CR | 0 | 1 | 2 | Obs | 0 | 124 | — | 0 |
6 | (RA)DA-151 | CR | 0 | 1 | 2 | Obs | 0 | 488 | — | 0 |
7 | DA | CR | 0 | 1 | 1 | — | — | 119 | — | 0 |
8 | DA | CR | 0 | 2 | — | — | — | 47 | — | 0 |
9 | DA | CR | 0 | 1 | 2 | RA | 142 | 258 | 0 | 142 |
10 | DA | CR | 0 | 1 | 2 | RA | 365 | 566 | 90 | 365 |
11 | DA | CR | 0 | 1 | 2 | RA | 365 | 821 | 344 | 365 |
12 | DA-RA(OP) | 1°Res-CR-152 | 82 | 1 | 0 | RA(OP) | 99 | 128 | 30 | 181-153 |
13 | RA | CR | 42 | 0 | 2 | Obs | 0 | 334 | 334 | 42 |
14 | RA | CR | 52 | 0 | 2 | (RA)Obs-155 | 0 | 188 | 174 | 52 |
15 | RA-DA | 1°Res-CR¶ | 44 | 1 | 2 | Obs | 0 | 522 | 540 | 44 |
16 | RA-DA(OP) | Dc-CR# | 19 | 1 | 2 | — | 0 | 348 | 410 | 19 |
17 | RA | CR | 50 | 0 | 2 | RA | 365 | 563 | 49 | 415 |
18 | RA | CR | 73 | 0 | 2 | RA | 97 | 202 | 0 | 275 |
19 | RA | Tox/CR-160 | 23 | 0 | 0 | — | — | 192 | 189 | 23 |
20 | RA(OP)-164 | CR | 39 | 0 | 0 | RA(OP)-164 | 312 | 324 | 0 | 351-153 |
Abbreviations: Rx, treatment; Proto, protocol; DA, daunorubicin-cytarabine; CR, complete remission; RA, all-transretinoic acid; 1°Res, primary resistance; OP, off protocol; Obs, observation; Dc, discontinued; Tox, toxicity.
Cases no. 1 through 19 were previously untreated as required by protocol E2491/INT0129; case no. 20 was a non-protocol case who had been treated with 6 cycles of doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) for breast cancer 2 years before developing APL.
Case no. 6 was randomized to RA but did not receive it because we were unable to reduce the WBC count to less than 10,000/μL using hydroxyurea per protocol; the patient then received protocol-specified cross-over DA.
Case no. 12 developed prolonged marrow hypoplasia after 1 course of induction chemotherapy and was subsequently treated off-protocol with RA (45 mg/m2/d).
After relapse from RA-induced CRs, cases no. 12 and 20 were treated with intravenous liposomal RA (90 mg/m2 every other day) for 72 and 15 days, respectively, without clinical response.
Case no. 14 was re-randomized per protocol to receive RA maintenance therapy but refused further RA therapy.
¶Case no. 15 failed to achieve CR after 42 days of RA therapy, also complicated by acute thyroiditis, at which time the patient was crossed-over per protocol to DA and achieved CR.
#Case no. 16 developed cerebral aspergillosis after 19 days of protocol RA therapy, requiring discontinuance of this therapy; a subsequent CR was obtained off-protocol by DA.
Case no. 19 achieved CR after 20 days of RA therapy but concomitantly developed acute renal failure, after which all further therapy was suspended until clinical relapse.
Case no. 20 with secondary APL and doxorubicin-associated cardiomyopathy was treated with continuous RA therapy (45 mg/m2/d) until relapse.