A multicenter, phase II study of cisplatin, irinotecan and epirubicin (PIE) administered every 3 weeks in patients with unresectable, locally advanced/metastatic cervical carcinoma
Bibliographic record
Abstract
5103 Background: Recurrent and metastatic cervical cancer is not curable with conventional therapy, and the median survival is only about 9 months. High objective response rates have been reported with epirubicin and irinotecan/cisplatin regimens in this patient population and preclinical studies in vitro and in vivo have demonstrated synergistic effects when irinotecan is used in combination with cisplatin or other antineoplastic agents. We report the preliminary findings of a phase II study to evaluate this combination in women with metastatic/locally advanced cervical cancer. Methods: This was a multicenter, open-label, single-stage phase II, prospective trial to evaluate the efficacy and safety of the combination of PIE, in women with histologically or cytologically documented squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix that was unresectable, locally advanced or metastatic. Patients had to have measurable disease as defined by RECIST criteria. No prior chemotherapy for metastatic disease was permitted. Patients received epirubicin (50mg/m2), cisplatin (50mg/m2) and CPT-11 (100mg/m2) intravenously, once every 3 weeks and had tumor assessment performed every 2 cycles. Results: Twenty-two patients have been entered to date, with 21 evaluable for response and toxicity (1 is too early to be assessed). Ten patients had previous platinum chemotherapy and 19 patients had prior radiation. The most frequent adverse events experienced were anemia, leucopenia, fatigue, lymphopenia and alopecia. A total of 19 patients experienced a grade 3 or higher adverse event, occurring across 60 cycles (78%). The most common grade 3 or higher adverse events were leucopenia, neutropenia and lymphopenia. To date there have been 2 patients with complete responses (CR), 4 patients with partial responses (PR), 8 patients with stable disease at cycle 2 and 7 patients progressed after their first evaluation. The combined CR/PR response rate is 28.6%. Conclusions: PIE appears to be active in advanced/metastatic cervical cancer, with manageable toxicities. This study continues to accrue patients. No significant financial relationships to disclose.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".